Need for a probiotic inhaler.
Friday, the 17th of October, Yakult turned this product idea
down. A need for probiotic inhalers is
suggested by research indicating that direct pulmonary delivery of probiotics
could modulate the lung microbiota and immune response to help manage
respiratory conditions like asthma and infections. While current probiotic use
is often focused on the gut, inhaled
probiotics are being explored as a way to directly target lung
inflammation and dysbiosis, offering a localized approach for conditions where
oral probiotics are less effective.
Protection against bacteria,
fungi, and bacteria
Protection against bacteria and fungi involves physical barriers, such
as intact skin and proper hygiene; chemical defenses, like the natural acidity
of skin and antimicrobial peptides; biological mechanisms, such as the body's
innate and adaptive immune systems with specialized cells and antibodies; and
external controls, including disinfectants, sanitizers, and antifungal agents.
Practicing good hygiene, maintaining a healthy lifestyle, and using appropriate antimicrobial products
can help prevent infections.
Probiotic Lower PH Advantage
By lowering the pH in the gut and other
bodily environments, probiotics create an advantage for beneficial
microbes while inhibiting the growth of harmful, acid-sensitive pathogens. The
production of organic acids, like lactic acid and short-chain fatty acids
(SCFAs), is the primary mechanism
for this effect.
Displacement with Probiotics
Displacement with probiotics refers to the process where beneficial
bacteria physically outcompete and
remove harmful pathogens from a surface, such as the gut lining or a
medical device. Probiotics achieve this through various mechanisms, including
producing surface molecules that bind to adhesion sites or inhibiting pathogen
communication (quorum sensing), which hinders their colonization and
contributes to overall health and wound healing
Competitive Exclusion
Microbial competitive exclusion describes how beneficial microbes (like probiotics) prevent harmful
pathogens from colonizing a habitat by outcompeting them for essential
resources like nutrients and attachment sites on a surface, thereby protecting
the host from infection. This natural bio-protective mechanism can be enhanced
by introducing beneficial microbial communities, often found in commercial
products, to out-compete pathogens for resources and prevent their harmful effects.
Formulation
Dry Powder Inhaler Formulation of
Lactobacillus rhamnosus GG Targeting Pseudomonas aeruginosa
Infection in Bronchiectasis Maintenance Therapy
National Institutes of Health (NIH)
| (.gov)
https://pmc.ncbi.nlm.nih.gov/articles/PMC11357607/
By TT Tran · 2024 · Cited by 5
The inhaled delivery of lactic acid bacteria (LAB) probiotics has been
demonstrated to exert therapeutic
benefits to the lungs due to LAB’s immunomodulatory activities. The
development of inhaled probiotics formulation, however, is in its nascent stage limited to nebulized LAB. We developed
a dry powder inhaler (DPI) formulation of Lactobacillus rhamnosus GG (LGG)
intended for bronchiectasis maintenance therapy by spray freeze drying (SFD).
The optimal DPI formulation (i.e., LGG: mannitol: lactose: leucine = 35: 45:
15: 5 wt.%) was determined based on the aerosolization efficiency (86% emitted
dose and 26% respirable fraction) and LGG cell viability post-SFD (7 log CFU/mL
per mg powder).
Repurpose
Commercial-off-the-shelf products
Repurposing Commercial Off-the-Shelf (COTS) products, also known as
Modified COTS (MCOTS), is the process of taking a standard, commercially available product
and modifying it for a specialized application. This is typically done by
adding custom features, software, or components to meet unique requirements
that the original product does not address.
GIT Analogy
>Many of the references in
this paper discuss the effects of probiotics on the Gastrointestinal tract (GIT). Any time you see reference to the
GIT you can substitute Respiratory Tract and features.
This analogy suggests that the mechanisms and effects observed in the
GIT regarding probiotics, such as their influence on the immune system, barrier
function, and microbial balance, can be conceptually
applied to the Respiratory Tract. Therefore, when encountering
discussions about probiotics and the GIT in the paper, the reader should
consider the potential parallels and implications for the Respiratory Tract,
including its structures (e.g., lungs, bronchi) and functions (e.g., immune
response, mucus production). This allows for a broader understanding of probiotic action beyond the gut.
Repurposing Yakult Culture as
Inhaler Ingredient
Repurposing Yakult culture as an inhaler ingredient is highly speculative and presents
significant safety and technical challenges. While recent research
explores inhaled probiotics for respiratory health, the direct use of a
commercial food product like Yakult for inhalation is dangerous and unproven.
Scientific and safety concerns
Intended for the gut, not the
lungs
The Lacticaseibacillus paracasei Shirota strain found in Yakult is
intended for the gastrointestinal (GI) tract, where it is generally recognized
as safe for consumption. The lungs have a delicate and different microbial
environment, and introducing high concentrations of a food-grade bacteria could
cause a severe inflammatory response
or infection, especially for individuals with compromised immune
systems.
Risk of aspiration pneumonia
The normal function of the lungs is to manage the exchange of gases.
Inhaling any foreign substance, especially a non-sterile, dairy-based liquid
like Yakult, can cause aspiration pneumonia, a serious lung infection.
Unsuitable formulation
Yakult is a liquid containing milk, sugars, and natural flavorings.
Inhaling these substances could cause damage and irritation to the sensitive
lung tissue. In contrast, new research on inhaled probiotics uses specifically engineered dry powder
formulations to ensure proper delivery and minimize harm.
Risk of infection
While the Shirota strain is generally benign in the gut, there are rare
but documented cases of probiotic-associated infections in vulnerable patients
when bacteria were introduced outside of the GI tract. The specific risks of
introducing this strain into the lungs are unknown
and untested.
Emerging research on inhalable
probiotics
Though repurposing Yakult is dangerous, researchers are investigating the therapeutic potential of
inhaled probiotics to treat respiratory diseases by modulating the lung's
microbiome.
Engineered for safe inhalation
Unlike Yakult, these experimental probiotics are engineered into dry powder or aerosolized formulations
that are optimized for lung delivery and viability. Researchers have already
developed and tested formulations with other strains of Lactobacillus in animal models.
Potential for lung disease
treatment
Preliminary animal studies suggest that inhaling live Lactobacillus can
reduce inflammation and improve lung
function in chronic lung diseases like Chronic Obstructive Pulmonary
Disease (COPD).
Under clinical investigation
The safety and efficacy of these treatments in humans are still under
investigation, with clinical trials
being planned to test their viability.
Experimental
Attempting to use Yakult as an inhaler ingredient is dangerous and
ill-advised due to the high risks of infection, inflammation, and aspiration
pneumonia. The commercial product is not formulated for respiratory use and is
intended only for consumption. The scientific interest in using probiotics for
respiratory therapy is real, but it is limited to experimental, specifically
engineered formulations, and remains a
subject of ongoing clinical research.
Patent V Produce
"Patent V Produce" likely refers to patents for a product (or
"produce"), which are a type of intellectual
property that grants the inventor the right to exclude others from
making, using, or selling their invention for a limited time. While you can
protect a product with a patent, the phrase could also be a play on words,
implying that patents are a type of "produce" or output that can be
generated by inventors and companies.
Probiotic Nasal Spray (PNS)
Probiotic nasal rinses may
contribute to restoring microbial homeostasis by reducing genera
associated with inflammatory dysbiosis in nasal inflammatory diseases, warranting
further research on their clinical benefits.
Probiotic Metered Inhaler (PMI)
A "Probiotic Metered Inhaler" (PMI) is not a current or approved medical device; rather, it is a
conceptual idea of combining probiotics with the delivery mechanism of a standard
metered-dose inhaler (MDI). While research
suggests probiotics may offer benefits for managing respiratory
conditions like asthma, such as reducing infections and improving symptoms,
they are typically administered orally as supplements, not through an inhaler.
Sharing the Idea
LDC and Keith Torkelson met and
shared a room at UC Davis. LDC had a
successful career in the pharmaceutical industry. Back in 2021, we ran our idea by him. He said it would cost in the millions to
develop.
Test Kit – Ruling out Nasal Spray
>This is the test model for
Probiotic product 1: Probiotic Nasal Spray (PNS). We could not tell if using it was beneficial
yet we do know we suffered no adverse effects.
Need for a Probiotic Inhaler
A need for probiotic inhalers
exists as an emerging area of
research to improve respiratory health, especially for conditions like asthma
and cystic fibrosis, by modulating the lung microbiota and immune response.
While still largely in pre-clinical
stages and not widely available, potential benefits include reducing
airway inflammation, increasing beneficial microbes, and providing an
alternative or adjunctive therapy to traditional treatments by leveraging the
gut-lung axis.
Potential Benefits of Probiotic
Inhalers
Modulate Lung Microbiota
A probiotic inhaler could deliver beneficial microbes directly to the
lungs, helping to restore a healthy balance and keep pathogenic bacteria in
check.
Reduce Airway Inflammation
Probiotics can interact with the host's immune system, potentially
promoting anti-inflammatory cytokines and strengthening the epithelial barrier
of the respiratory tract, which reduces inflammation.
Treat Respiratory Diseases
Research is ongoing into their
potential use for conditions like…
Asthma
Probiotics can help regulate immune responses and potentially alleviate
asthma symptoms and control exacerbations by modulating the gut-lung axis.
Cystic Fibrosis
They may be beneficial in keeping
pathogenic microflora in check, particularly during antibiotic therapy,
and could aid in restoring a healthy lung microbiome
Bronchopulmonary Dysplasia
Inhaled delivery of probiotics has shown potential to reduce
inflammation in this chronic lung disease of prematurity.
How It Works (The Gut-Lung Axis)
The gut and lungs are connected through the "gut-lung axis,"
where the health of the gut microbiome influences lung health and vice versa. Probiotics can act as immunomodulators,
altering the host's immune response through this axis to achieve therapeutic effects in the lungs.
Current Research and Future
Directions
While many studies focus on the oral or intranasal delivery of
probiotics for respiratory conditions, very
few have focused specifically on the inhaled route. Early pre-clinical studies have shown
promising results, including the inhibition of lung cancer metastases and
modulation of lung microbiota, but more human clinical trials are needed. Developing specific probiotic formulations,
understanding the ideal strains, and determining effective delivery methods are
key areas for future research to realize
the potential of probiotic inhalers.
Aside - How to write a technical
paper or a research paper
https://homes.cs.washington.edu/~mernst/advice/write-technical-paper.html
[Write one sentence for each
section of the paper]
Need
>This paper addresses a product gap and unmet need about
the use of probiotics in the human respiratory system. The product(s) described here are
prophylactic and protective in nature.
Overview
Probiotic Nasal Spray (PNS) and
Probiotic Metered Inhaler (PMI)
>The paper roughly follows the
combined formats for a standard research paper and a project management
scheme. Preliminary research indicates
that probiotics are not widely used
as a preventative strategy against respiratory illness, such as coronavirus-related illness. The need for probiotics
is growing day by day.
Product Line
>We addressed two product
lines. The simpler of the two is our
Nasal Probiotic Spray (NPS). Nasal
Probiotic Sprays appear to be on the market.
Thus, we abandon our NPS scheme. The
more complex product is our per os or Oral
Inhaler System. If need be, we
will give our idea away. We are looking into
how much it will cost to produce and test the probiotic inhaler system. We intend to provide the idea for Yakult, a local
distributor of liquid probiotic-based beverages.
First Things First
>We have tested the nasal
spray prototype three times. Our test subject,
“Buster,” did not experience any adverse effects such as sore throat, runny
eyes, itchy eyes, worsening of COPD, or redness around his nostrils. In the long run, for efficacy studies, we
suggest using a Leghorn Chicken
Model (LCM). Lessons learned
from our NPS work are applied to the Inhaler.
Probiotic selection will be addressed later in the paper.
Leghorn Chicken Model for
Respiratory Research
Leghorn chickens, particularly Specific
Pathogen-Free (SPF) White Leghorns, are a valuable model for
respiratory research due to their well-characterized genetics, consistent
immune response, and unique
respiratory anatomy. Researchers use them to study infectious diseases,
test vaccines, and investigate fundamental avian respiratory biology.
Time Tables
>We suggest a one-year timeline for developing and patenting the Oral Metered Inhaler (OMI AKA pMDI). The OMI project will close after a reasonable
number of tests with human subjects. The
inhaler will dominate a substantial-sized market. Proof of concept is how well it sells. Engineering drawings and documents will be
submitted with this report. We are
working with a timeline of specific release of this report on October 31,
2021 now or around October 31, 2025, because the unmet needs outweigh making a
profit. We hope that Yakult with give us
a stake in the OMI product.
Material – Diagram of Inhaler -
Modified
Material List – Modified -
Diagram
Gas Phase of Inhaler
The "gas phase" of an inhaler refers to the propellant gas
that is liquefied under pressure within the inhaler canister. When the inhaler
is activated, this compressed gas expands into its gaseous state, driving the
medication aerosol out of the nozzle and into the patient's lungs. Modern
inhalers use hydrofluoroalkane (HFA)
propellants, which replaced older chlorofluorocarbons (CFCs).
Probiotic Inhaler Formulation
Probiotic inhaler formulations
are in development, typically involving a dry powder inhaler (DPI) that
requires micronized probiotics mixed with a carrier like lactose. Key steps
include creating a stable, dry powder through techniques like spray
freeze-drying, selecting a suitable
formulation with excipients (like mannitol and leucine), ensuring the
probiotic's viability and aerosolization efficiency, and assembling the powder
into a device. Alternatively, nebulized formulations are also being explored,
using liquids containing probiotics for delivery, but this is in earlier stages
of development.
Method – Inhaler Charging
Pressurized Metered Dose Inhaler (pMDI)
Technology: Manufacturing
https://www.semanticscholar.org/paper/Pressurized-Metered-Dose-Inhaler-Technology%3A-Vallorz-Sheth/0c6fcfc4335a83a5e6214e4e571562a9748eaaee
Ernest Vallorz, P. Sheth, P.
Myrdal (Published 2019)
Metered Dose Inhalers
While first introduced in the 1950s, pressurized metered dose inhalers
(pMDIs) remain a first-line treatment of pulmonary conditions. With expanding applications of pMDIs
beyond asthma and chronic obstructive pulmonary disease (COPD), the development
of therapies utilizing the pMDI platform
will undoubtedly continue. Recent guidances and the introduction of quality by
design initiatives further emphasize the requirement
of formulators to understand the relationships between product
attributes and production strategies and their impact on product performance.
Manufacturing
This review summarizes common manufacturing processes of pMDIs across
multiple stages of the development cycle, from academia to commercial
production, and provides insight as to the benefits
and limitations of each process regarding formulation type.
Crimping
Method – Pressure Filling
Two-Stage Pressure Filling
Single-Stage Cold Filling
Two-Stage Cold Filling
Process Stages
Advantages & Disadvantages
Critical Quality Attributes
The Problem Revisited –
Respiratory Illness
Respiratory illnesses affect your lungs and airways, making it hard to
breathe. These illnesses share common symptoms, risk factors, and prevention
strategies. In the United States, we have more
tools than ever before to help people protect themselves, their
families, and communities from severe respiratory illnesses.
Post-Antibiotic Colonization
Post-antibiotic colonization refers to a period after antibiotic
treatment when the gut microbiome, the complex community of microbes in the
digestive system, is disrupted and can be more
susceptible to colonization by new or pathogenic bacteria, including
antibiotic-resistant bacteria. This imbalance can increase the risk of
infection. To support recovery and prevent harmful colonization, it's
recommended to consume a varied diet rich
in prebiotic fibers from vegetables, legumes, and fruits, and
incorporate live-culture fermented foods, rather than relying solely on
probiotics, which can sometimes delay recovery by hindering the return of
unique, diverse microbes.
Probiotic Research
Recent studies indicate that probiotics may assist in the regulation of
weight and blood glucose levels and influence metabolism and insulin
sensitivity. Emerging research indicates that the “gut-brain axis” connects mental and gastrointestinal
health.
Facilities for working with
probiotics
Facilities for working with probiotics include academic research
centers, quality control laboratories, and industrial
manufacturing plants, which often specialize in specific stages of
probiotic development and production. These facilities vary in size and
capability, from small labs focused on strain identification to large-scale,
cGMP-certified factories.
FYI > Metadata >
https://www.uclahealth.org/departments/medicine/gastro/microbiome/cores/human-probiotic-core#:~:text=We%20collaborate%20closely%20with%20researchers,phase%20of%20their%20microbiome%20research.
Staff
Our core is staffed with experienced professionals who offer
comprehensive support at every stage of the research process. We collaborate closely with researchers to
fine-tune probiotic formulations, taking into account the nuances of both aerobic and anaerobic cultures.
Moreover, we provide guidance on navigating the intricate regulatory
frameworks, such as IND, GRAS designation, and FDA/IRB compliance, to ensure
that research protocols meet all necessary criteria. Additionally, we
collaborate with the Technology and Development Group (TDG) at UCLA to aid
researchers in bringing their
probiotic research to the market.
Facilities
The Human Probiotic Core houses state-of-the-art facilities tailored to
the unique demands of probiotic research, with dedicated spaces for both
aerobic and anaerobic cultures, freeze drying, and pill packaging. By aiding
researchers in transforming their
concepts into evidence-based solutions, we aim to help investigators
transition to the next phase of their microbiome research.
Material & Method
Test Phase - Experimental Bunny
Rabbit
Leghorn Chickens in respiratory
research
Leghorn chickens are used in respiratory research to study disease resistance, the effects of respiratory pathogens
like Newcastle disease virus (NDV) and Ornithobacterium rhinotracheale (ORT),
and the impact of factors like pulmonary vascular resistance and salt-induced
pulmonary hypertension. They serve as a control breed to compare with
fast-growing broilers, revealing Leghorns' distinct physiological responses,
lower susceptibility to certain respiratory diseases, and avoidance of severe
pulmonary hypertension and associated pathological
lung changes.
Images
>The images used in this
report come from two main sources:
Photographs by the author and those pirated from the internet.
Staff (Brief)
Product Engineer
A Product Engineer designs, develops, tests, and oversees the entire
life cycle of a product, whether physical or digital, ensuring its quality,
usability, and performance. They
translate customer needs into product specifications, working with
technical feasibility, costs, and timelines to bring a product from concept to
completion. Key activities include building and testing prototypes, controlling
changes to construction and materials, gathering data, and collaborating across
different functions like design, engineering, and sales.
Others
Yakult's research staff are primarily based at two main facilities: the Yakult Central Institute in Tokyo,
Japan, and the Yakult Honsha European Research Centre in Ghent, Belgium. The
company employs hundreds of scientists and researchers who focus on
microbiology, probiotics, and preventive medicine.
Yakult Project Managers
Yakult is not a single project, but a company that hires project managers for various initiatives, such as
building new facilities like the recent Bartow County, Georgia, plant. Specific
project managers named include Mellissa Takeuchi, who was a Project Manager for
the Georgia Department during the location selection for the new Bartow County
facility, and Michael Finelli, identified as a Business/Project Manager at the
Yakult USA Manufacturing Plant. For general or international project management
roles at Yakult, one would typically find openings on professional networking
sites like LinkedIn.
Introduction
History of Probiotics
Probiotics have been part of the human diet for millennia, far predating
the scientific understanding of microorganisms. The history of probiotics
includes the ancient practice of consuming
fermented foods, the scientific discoveries of the early 20th century,
and the rise of the modern probiotic industry.
Early Usage
Evidence suggests that fermented foods and beverages, such as yogurt,
cheese, and wine, have been consumed
for thousands of years for their perceived health benefits. Ancient
civilizations, including the Egyptians, Greeks, Romans, and Indians, used
fermented products to improve digestion, prevent infections, and promote
overall well-being.
Scientific Discoveries
In the 19th century, French
chemist Louis Pasteur discovered the role of bacteria in fermentation.
Russian biologist Élie Metchnikoff proposed the theory that beneficial bacteria
could reside in the human gut and contribute to health. He observed that
Bulgarian peasants who consumed large amounts of yogurt lived long and healthy
lives. In 1907, Henry Tissier isolated
Bifidobacterium, a type of probiotic bacterium, from the feces of
infants. In 1989, the term
"probiotic" was coined by French microbiologist Raymond Kunz
and Canadian researcher Peter Stanton to describe live microorganisms that
provide health benefits to the host.
Modern Research
Since the 1980s, there has been a significant increase in research on
probiotics and their potential health benefits. Studies have shown that
probiotics can help improve gut health, reduce the risk of infections, boost the immune system, and promote overall well-being. The
use of probiotics has expanded beyond fermented foods to include supplements,
beverages, and even topical products.
Future Directions
Ongoing research is exploring the potential of probiotics in treating
various health conditions, such as inflammatory bowel disease, eczema, and
cancer. The development of new
probiotic strains and delivery methods is also a focus of attention. As our understanding of the gut microbiome and
its role in health grows, the field of probiotics is expected to continue
evolving and expanding.
Seasonal COPD - Lived Experience
with Antibiotics
Lived experiences of people with seasonal Chronic Obstructive Pulmonary
Disease (COPD) reveal that antibiotics are frequently used during
exacerbations, with treatment patterns and outcomes showing seasonal variation, such as peaks in
winter. While antibiotics can reduce exacerbations, patient-reported
quality of life benefits are mixed, and their effectiveness is inconsistent
across different exacerbation severities, with the most significant benefits
seen in severe cases. Drawbacks include the risk of side effects, costs, and
the potential development of antibiotic resistance.
Respiratory Probiotics
Probiotic Nasal Spray (PNS) and
Probiotic Metered Inhaler (PMI)
Nasal-spraying Bacillus spore
probiotics for pneumonia in children with respiratory syncytial virus and
bacterial co-infections: a randomized clinical trial
National Institutes of Health
(NIH) | (.gov)
https://pmc.ncbi.nlm.nih.gov/articles/PMC12328779/
By HT Le · 2025
Use of the probiotic reduces symptoms, antibiotic use, viral and
bacterial loads, and improves immune and nasal microbiota.
Pressured Probiotic Metered
Inhaler (pPMI) – Atomizer Option
What does an atomizer do?
“An atomizer consists of a small heating element, or coil, that vaporizes e-liquid and a wicking
material that draws liquid onto the coil. When the user inhales a flow sensor
activates the heating element that atomizes the liquid solution; most devices
are manually activated by a push-button.”
Atomizers to deliver probiotics
Atomizers deliver probiotics in ultra-fine mist form, either as a
skin-applied topical treatment or for lung
inhalation, and are sometimes used in research and development for
encapsulation techniques like electrohydrodynamic atomization. Topical misting
devices can apply probiotics to surfaces, while respiratory atomizers may deliver them to the lungs to
modulate the lung microbiota. In the broader context of delivery, atomization
is also a method for developing encapsulated probiotics for other delivery
routes.
We find that an Atomizer might
work.
Rule out nasal sprays - Early
Trials.
Probiotic Nasal Spray (PNS) –
Ruled out because there are already numerous products on the market.
Probiotic Metered Inhaler (PMI)
AKA Pressurized Probiotic Metered Inhaler (pPMI)
Method of choice
Figure
- Breaking it Down
[COPY
AND PASTE LINK – Security check required]
https://www.researchgate.net/figure/A-pressurized-medical-metered-dose-inhaler-pMDI-The-device-comprised-of-the-canister_fig1_265947820
Content
– Microbiology
Target
Agents - Respiratory Tract Pathogens
Example
of viruses of the respiratory tract
Respiratory
Viruses – NCBI
Encyclopedia
of Microbiology. 2009: 500–518.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7149556/
The respiratory viruses that most
commonly circulate in all continents as endemic or epidemic agents are:
Prevention
of
1.
Influenza Virus
2.
Respiratory
Syncytial Virus
3.
Parainfluenza
Viruses
4.
Metapneumovirus
5.
Rhinovirus
6.
Coronaviruses
7.
Adenoviruses
8.
Bocaviruses
Prevention
– Viruses up front
Published:
08 November 2022
Respiratory
illness virus infections with special emphasis on COVID-19
https://eurjmedres.biomedcentral.com/articles/10.1186/s40001-022-00874-x
[SEE
NEXT TWO PAGES]
How
many have died from COVID worldwide?
https://data.who.int/dashboards/covid19/deaths
How
much did COVID-19 affect the world?
The COVID-19 pandemic killed nearly 16 million people worldwide in 2020 and
2021 and caused global life expectancy to decline by 1.6 years between
2019 and 2020. However, it did not erase the progress of the past 72 years.
Between 1950 and 2021, global life expectancy increased by almost 23 years from
49 to 71.7 years. Mar 11, 2024
Target
Agents - Example of Fungi of the Respiratory Tract
Respiratory
Mycoses | Microbiology - Lumen Learning
Respiratory
Mycoses | Microbiology (lumenlearning.com)
https://courses.lumenlearning.com/microbiology/chapter/respiratory-mycoses/
These include bread molds, like Rhizopus
and Mucor; the most commonly associated species is Rhizopus arrhizus (oryzae)
(see Figure 4 in Fungi). These fungi can colonize many different tissues in
immunocompromised patients, but often
infect the skin, sinuses, or lungs.
Pathogenic
Fungal Infection in the Lung – NCBI (2019)
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6616198/
FAQ
- Which are the 3 most common respiratory diseases caused by fungi?
Respiratory fungal infection is a severe
clinical problem, especially in patients with compromised immune functions…
1.
Aspergillus
2.
Cryptococcus
3.
Pneumocystis
4.
Endemic fungi
…are major pulmonary fungal pathogens
that can result in life-threatening invasive diseases. Jul 3, 2019
Target
Agents - Example of Bacteria of the
respiratory tract
Respiratory
Illnesses: 13 Types of Lung Infections
Reviewed
By Charles Patrick Davis, MD, PhD on 3/20/2020
[LINK
BROKEN]
https://www.onhealth.com/content/1/respiratory_infections_causes
1.
Streptococcus
pneumoniae
2.
Haemophilus
influenzae
3.
Moraxella
catarrhalis
…are
the most common bacterial pathogens in upper and lower respiratory tract
infections.
Streptococcus
pyogenes…
…is
the predominant bacterial pathogen in pharyngitis and tonsillitis
What are the 20 diseases of
the respiratory system?
https://www.lung.ca/lung-health/lung-diseases
Lung diseases A to Z
1. Asbestosis
2. Asthma
3. Bronchiectasis
4. Bronchitis
5. Chronic cough
6. Chronic obstructive pulmonary disease (COPD)
7. Common cold
8. COVID-19
9. Croup
10. Cystic fibrosis
11. Hantavirus pulmonary syndrome
12. Influenza (flu)
13. Interstitial lung disease (ILD)
14. Long COVID
15. Lung cancer
16. Pertussis (whooping cough)
17. Pleurisy
18. Pneumonia
19. Pulmonary embolism
20. Pulmonary fibrosis
21. Pulmonary hypertension
22. Pulmonary sarcoidosis
23. Respiratory syncytial virus (RSV)
24. Sleep apnea
25. Sudden infant death syndrome (SIDS)
26. Tuberculosis
Microbiology
of Bacterial Respiratory Infections – PubMed (1998)
https://pubmed.ncbi.nlm.nih.gov/9727651/
Agents
The upper respiratory tract may become susceptible to
bacterial infection as a result of health conditions such as allergies and
viral infections, as well as the effects of smoking and airborne environmental
pollutants. Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella
catarrhalis are the most common bacterial pathogens in upper and lower
respiratory tract infections. Streptococcus pyogenes is the predominant
bacterial pathogen in pharyngitis and tonsillitis. Bacterial pathogens adhere to mucous membranes, and colonization
ensues. In an otherwise healthy individual, the host immune system
responds to the invading bacteria, resulting in edema and swelling.
Treatment
If antimicrobial treatment does not eradicate
the invading organisms and successfully interrupt the progress of the
infection, the patient may develop
recurrent or chronic disease. S. pneumoniae and other pathogens, once
susceptible to penicillin and other antibiotics, are now becoming resistant.
Bacterial resistance has developed and disseminated because of the widespread
use of antibiotics. Major mechanisms of bacterial
resistance to antimicrobials in upper respiratory tract infections
include enzymatic inhibition, membrane impermeability, alteration of target
enzymes, active pumping out of antibiotics, and alteration of the ribosomal
target.
FAQ
- What are the 2 most common respiratory tract infections?
The common
cold and influenza (the flu) are two of the most common respiratory
tract infections, with the common cold being a very frequent viral upper
respiratory tract infection and influenza affecting the upper and sometimes
lower respiratory tracts. While pneumonia is a common lower respiratory tract
infection, colds and flu are more prevalent overall.
Preventing
Microbial Infections
Preventing microbial infections involves
practicing good personal hygiene, like frequent handwashing, staying up-to-date
on vaccinations, practicing safe food handling and food safety, avoiding
contact with sick people, covering coughs and sneezes, staying home when you
are sick, and disinfecting frequently touched surfaces. These simple steps help
reduce the spread of germs and protect
against various infections.
Infections
of the Respiratory System - Medical Microbiology – NCBI
https://www.ncbi.nlm.nih.gov/books/NBK8142/
Target
Infections - Prevention
General
Concepts
Upper
Respiratory Infections
1.
Common Cold
2.
Sinusitis
3.
Pharyngitis
4.
Epiglottitis
5.
Laryngotracheitis
Etiology
Most upper respiratory infections are of viral etiology.
Epiglottitis and laryngotracheitis are exceptions, with severe cases likely
caused by Haemophilus influenzae type b. Bacterial pharyngitis is often caused
by Streptococcus pyogenes.
Lower
Respiratory Infections
1.
Bronchitis
2.
Bronchiolitis
3.
Pneumonia
How do probiotics affect viruses?
Probiotics at War Against
Viruses: What Is Missing From the Picture?
Frontiers
https://www.frontiersin.org/articles/10.3389/fmicb.2020.01877/full
Can Health-Promoting Commensal
and Probiotic Bacteria Defend Against Pathogenic Viruses?
In this review, we focus on the antiviral
potential of lactic acid bacteria (LAB) probiotics and their secondary
metabolic compounds and discuss the transfer of viruses between animals and
humans. Current and past research efforts into the use of probiotics and/or
their metabolites to combat viral infections are sorely lacking. As such, an
objective of this review is to not only discuss these research efforts, but
also to use this information to outline a roadmap that may be used to help
structure and focus future research efforts toward the use of probiotics in the
control of viral infections.
Bacteriocin-Producing
Bacteriocin-producing organisms, such as specific strains of lactic
acid bacteria (Lactobacillus) and some E. coli species, are microbes that
generate antimicrobial peptides
called bacteriocins. These bacteriocins are small proteins that kill other
bacteria and are produced naturally by a variety of bacteria and archaea. They
are used to control pathogenic bacteria in the gut, as probiotic supplements,
and in food preservation as bio-preservatives.
Probiotics and Prophylaxis
Probiotics, beneficial live
microorganisms, can be used for prophylaxis, the prevention of disease,
to maintain gut health, and boost immunity. They help prevent conditions like
antibiotic-associated diarrhea and Clostridium difficile infection by competing with pathogens for
nutrients and binding sites. Prophylactic use is also being explored for
conditions such as postoperative infections and preterm birth.
Can Health-Promoting probiotics
prevent against pathogens?
Yes, health-promoting probiotics can help prevent pathogens by outcompeting them for space and
nutrients, producing antimicrobial substances, strengthening the gut barrier to
prevent pathogen entry, and enhancing the host's immune response. These mechanisms collectively reduce
pathogen colonization and infection risk, though more standardized research is
needed for specific applications.
Front. Microbiol., 20 August 2020
| https://doi.org/10.3389/fmicb.2020.01877
Biologicals
Biologicals are diverse therapeutic or agricultural products derived from living organisms or their
components, distinct from conventional synthetic medicines and
chemicals. In medicine, they include vaccines, antibodies, and growth factors,
which are regulated extensively to ensure safety and consistency. In
agriculture, biologicals encompass biofertilizers, biostimulants, and
biocontrols, using microorganisms and natural extracts to enhance crop health
and yield.
Pathogens
Pathogens are tiny organisms
that can make you sick if they get inside your body. Viruses, bacteria, fungi,
parasites, and prions are pathogens. They're commonly called germs. Handwashing,
disinfecting surfaces, and safe food preparation can reduce your risk of getting
infected with a pathogen. Jun 17, 2025
Molecular Pathogens
"Molecular pathogens" refers to the study of pathogens, such
as viruses and bacteria, at the
molecular level, focusing on their molecular patterns, genomes, and how they interact with a host's
molecular systems to cause disease. It also refers to molecular methods used to
detect, characterize, and understand pathogens, including techniques like DNA
sequencing and polymerase chain reaction (PCR), which are highly specific and
sensitive tools for identifying pathogens and even determining antibiotic
resistance.
Commensal and Probiotic Bacteria
Commensal bacteria reside on and within the human body without causing harm,
maintaining a balanced ecosystem, while probiotics are specific, beneficial
microorganisms (often bacteria or yeasts) that, when consumed in adequate
amounts, provide measurable health
benefits to the host. Essentially, probiotics are a subset of
beneficial commensal bacteria that have been isolated, characterized, and shown
to exert specific positive health effects, such as aiding digestion or
supporting the immune system.
Lactic Acid Bacteria (LAB)
Lactobacillales are an order of gram-positive, low-GC, acid-tolerant,
generally nonsporulating, nonrespiring, either rod-shaped or spherical bacteria
that share common metabolic and
physiological characteristics.
Bacteriocin-Producing [DITTO]
Bacteriocin-producing refers to bacteria
and archaea that naturally synthesize and secrete bacteriocins, which
are antimicrobial peptides.
Common bacteriocin-producing organisms include lactic acid bacteria (LAB), such
as Lactobacillus, Lactococcus, and Enterococcus, as well as bacteria like
Escherichia coli. These bacteria use bacteriocins to inhibit the growth of
other, often pathogenic, bacteria, playing a significant role in microbial
communities and holding potential as food preservatives and antibiotic alternatives.
Probiotic
Probiotics are live microorganisms
in foods intended to improve or restore microbiota in the gut.
Probiotic products include yogurt, cheese, some fermented foods, such as
sourdough bread and nattō, dietary supplements, and clinical capsules
containing a specific probiotic strain.
Gut Microbiota
Gut microbiota, gut microbiome, or gut flora are the microorganisms,
including bacteria, archaea, fungi, and viruses, that live in the digestive
tracts of animals. The gastrointestinal metagenome is the aggregate of all the
genomes of the gut microbiota. The gut is the main location of the human microbiome.
Lung Microbiota - Metagenome
A lung metagenome is the entire
genetic material from the microbial community in the lungs, and
metagenomics is the study of this material to understand the different types of
microbes present and their functional capabilities, which can provide insights into lung health and disease.
Techniques like shotgun sequencing analyze all genes in the community, helping
to identify microbes and their potential functions, but are challenged by the
high ratio of human to microbial DNA in the lungs.
Anti-Viral
Antiviral medications are a class of drugs designed to treat viral
infections. They work by interfering
with the replication and spread of viruses within the body, helping the
immune system fight off the infection more effectively.
Protective Factors
Protective factors are conditions or characteristics at the individual,
family, community, or societal level that act
as assets, buffering stress (disease) and reducing the likelihood of
negative outcomes, such as mental health issues or adverse life events. These
factors build resilience by promoting healthy development and helping people to
cope more effectively with
life's challenges. Examples include internal traits like strong self-esteem and
positive coping skills, as well as external support such as supportive relationships
and community resources.
Protective Factors against
microbial pathogens
Protective factors against microbial pathogens include the physical
barrier of the skin and mucous membranes, chemical barriers like stomach acid
and antimicrobial substances, beneficial microbial communities (the normal
flora), the host's immune system (innate and adaptive immunity), and general
health factors such as good nutrition, fever, and hygiene. These factors work
together to prevent pathogens from
invading and causing disease.
FYI - Probiotic Effects against
Virus Infections: New Weapons for an Old War
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7827890/
by A Lopez-Santamarina · 2021
Keywords: probiotic, gut
microbiota, viral infection, viruses, influenza.
Foods. 2021 Jan; 10(1): 130.
Probiotic Administration
Probiotic administration involves introducing
live microorganisms that confer health benefits to the host, typically
through oral consumption via fermented foods, supplements, or encapsulated
forms to protect them from the harsh digestive environment. Other applications
include spray or feed application in animal agriculture and, more rarely,
topical use in beauty products. The method of administration must ensure the probiotics reach the gut
intact to exert their effects.
Pathogens
Pathogens are disease-causing
biological agents, such as bacteria, viruses, fungi, parasites, and
prions, that invade a host organism like a human, animal, or plant to cause
illness. They survive by colonizing the host, overcoming immune defenses,
replicating, and spreading to new hosts through various routes, including direct
contact, contaminated surfaces, contaminated food or water, or vectors like
ticks and mosquitoes.
Aside - Why use an intranasal
probiotic spray?
Intranasal probiotic sprays are used to promote a healthy nasal microbiome, which can help to
alleviate symptoms of respiratory infections like viral and bacterial symptoms
and reduce recovery time by balancing
the microbial environment in the nasal passages. They work by
introducing beneficial bacteria that can reduce harmful microbes, decrease
pro-inflammatory cytokines, and strengthen the mucosal barrier.
COPD before Corona
Annual COPD Cycle
An "Annual COPD Cycle" can refer to the seasonal pattern of COPD exacerbations, with peaks often
observed in the winter months due to increased respiratory viral infections and
inflammation, or it can refer to the recommended annual clinical care schedule
for managing COPD, which includes regular follow-up appointments, assessments,
and treatments to help control the
disease and slow its progression.
Cigarette Smoker – COPD Risk
Factor
There is mounting evidence that the rate of progression of COPD can be
reduced when patients at risk of developing the disease stop smoking, while
lifelong smokers have a 50% probability of developing COPD during their
lifetime.
COPD Symptoms
Chronic obstructive pulmonary disease (COPD) is a lung condition that
causes inflammation and narrowing of
the airways, leading to breathing difficulties. Common symptoms of COPD
include:
Persistent cough
A persistent, mucus-producing cough that lasts for at least three months a year for two consecutive
years is the definition of chronic bronchitis, a type of chronic obstructive
pulmonary disease (COPD). It occurs when the airways become inflamed and filled
with mucus. Other common causes of chronic cough include smoking, asthma,
postnasal drip, and gastroesophageal reflux disease (GERD).
Shortness of breath
Shortness of breath, especially during physical activity or when lying
down, can indicate underlying heart
or lung problems like heart failure, asthma, or COPD. When this symptom
occurs during exertion, it can be a sign of dyspnea or pulmonary hypertension.
Experiencing it when lying down (orthopnea) is often linked to congestive heart
failure. You should see a doctor for this symptom, and seek immediate medical
attention (\(911\)) if it is severe, accompanied by chest pain, or a sudden
inability to breathe.
Wheezing
Wheezing is a high-pitched whistling sound during breathing caused by
narrowed or blocked airways, indicating potential
respiratory issues. Common causes include asthma, COPD, respiratory
infections like pneumonia or bronchitis, allergies, and inhaling a foreign
object. It's important to see a healthcare provider if wheezing is persistent,
severe, or accompanied by other symptoms like difficulty breathing or blue/gray
skin.
Chest tightness
A feeling of pressure or tightness in the chest.
Fatigue
Feeling tired or lacking energy.
Increased mucus production
Producing more mucus than usual, which may be clear, white, yellow, or
green.
Frequent respiratory infections
An increased risk of developing pneumonia, bronchitis, and other lung
infections.
Blueish tint to the skin or lips
This can indicate low oxygen levels in the blood.
Swelling in the legs or ankles
This can be a sign of right-sided heart failure, which can sometimes
occur in people with COPD.
Other symptoms may include
Difficulty sleeping, Difficulty concentrating, Poor appetite, Weight
loss, and coughing up blood (rare).
Important Note
It's important to note that symptoms of COPD can vary in severity and
may worsen over time. If you experience any of these symptoms, it's essential
to consult a healthcare professional
for proper diagnosis and treatment.
What does bloody mucus indicate?
Bloody mucus (hemoptysis) indicates bleeding in the airways or lungs and can signal a range of
conditions from minor irritation, like severe coughing or inflammation, to more
serious issues like bronchitis, pneumonia, bronchiectasis, tuberculosis,
pulmonary embolism (blood clot in the lungs), or even lung cancer. If you are
coughing up blood, even a small amount, it's crucial to see a doctor to
determine the underlying cause and receive appropriate treatment.
Antibiotics for seasonal COPD
Antibiotics are used to treat COPD exacerbations when bacterial infection is suspected,
typically indicated by a combination of increased shortness of breath,
increased mucus, and a change in mucus color. Common antibiotics for mild to
moderate exacerbations include amoxicillin with clavulanic acid, doxycycline,
and macrolides like azithromycin. Guidelines recommend a short course of 5 days
for many patients, though duration may vary based on severity and patient
characteristics.
Probiotics to treat seasonal COPD
While early research, especially in animal models, shows promise for probiotics in managing
COPD-related lung inflammation and damage, large-scale
human studies are still needed to confirm their efficacy for treating
seasonal COPD in people. Some studies suggest probiotics may offer benefits in
the gut-lung axis, and a recent study found a positive link between probiotic
supplementation and improved outcomes in COPD patients receiving standard
treatment. However, probiotics are not
a proven treatment for seasonal COPD, and patients should discuss any
supplementation with their healthcare provider.
Probiotics after antibiotic
treatment
Taking probiotics after taking antibiotics. Antibiotics can disrupt the
gut microbiome, leading to an imbalance
in the beneficial bacteria that live in the digestive tract (and
respiratory tract). Taking probiotics after taking antibiotics can help restore this balance and improve
gut (lung) health. Benefits of taking probiotics after antibiotics: Reduce the
risk of antibiotic-associated diarrhea (AAD), improve gut function and
digestion, boost the immune system,
and promote overall well-being.
Aerobic Activity and COPD
Aerobic exercise is a key
part of COPD management, helping to ease symptoms, boost energy and
endurance, and improve quality of life by strengthening the heart and lungs.
Recommended activities include walking, biking, and swimming, performed for
20-30 minutes at least three times a week. It is crucial to exercise at a
moderate intensity, using the "talk test" to ensure you can still
converse, and to stop immediately if you experience
severe symptoms like dizziness, chest pain, or worsening shortness of
breath.
Work Done – COVID & COPD
https://ktork46.blogspot.com/2020/05/covid-19eradicationproposalcoronavirusi.html
https://ktork46.blogspot.com/2020/05/covid-19coronaeradicationstudycontinuat.html
https://brandnewdayhmo.blogspot.com/2018/09/double-xx-digital-appointment.html
Pathogen - Special Topic - Targeting
COVID-19
The potential application of probiotics
and prebiotics for the prevention and treatment of COVID-19
https://www.nature.com/articles/s41538-020-00078-9
By AN Olaimat · 2020
COVID-19 is a pandemic disease caused by the novel coronavirus severe acute respiratory syndrome
coronavirus 2 (SARS-CoV-2). This new viral infection was first identified in
China in December 2019, and it has subsequently spread globally. The lack of a
vaccine or curative treatment for COVID-19 necessitates a focus on other
strategies to prevent and treat the infection. Probiotics consist of single or mixed cultures of live
microorganisms that can beneficially affect the host by maintaining the
intestinal or lung microbiota,
which play a major role in human health.
Target COVID-19
At present, good scientific evidence exists to support the ability of
probiotics to boost human immunity, thereby preventing colonization by
pathogens and reducing the incidence and severity of infections. Herein, we
present clinical studies of
the use of probiotic supplementation to prevent
or treat respiratory tract infections. These data lead to promising
benefits of probiotics in reducing the risk of COVID-19. Further studies should
be conducted to assess the ability of probiotics to combat COVID-19.
FAQ - How do probiotics affect pathogenic bacteria?
Introduction - Mechanism –
Competitive Exclusion
Probiotic engineering: Towards
development of robust probiotic strains with enhanced functional properties and
for targeted control of enteric pathogens
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5422995/#:~:text=Probiotics%20can%20displace%20pathogens%20through,diseases%20%5B43%2C%2044%5D.
“Probiotics can displace
pathogens through stimulation of host immunity. There is considerable
evidence to support the notion that probiotics
displace pathogens in the Gastrointestinal Tract (GIT) through
stimulation of specific and non-specific immunity to inhibit bacteria causing
intestinal diseases.” May 8, 2017
Risk Management - Risk – Rare Septicemia
Can probiotics cause bacterial
infection?
“They Can Increase Infection Risk for Some. Probiotics are safe for the vast majority of
the population, but may not be the best fit for everyone. In rare cases, the
bacteria or yeasts found in probiotics can enter the bloodstream and cause
infections in susceptible individuals.” Dec 17, 2017
Antimicrobial Effect of Probiotics
against Common Pathogens
https://www.intechopen.com/books/probiotics-and-prebiotics-in-human-nutrition-and-health/antimicrobial-effect-of-probiotics-against-common-pathogens
By S Fijan · 2016
Probiotics, together with other beneficial microbes, are commensals of
the gut and differ from pathogenic bacteria in terms of their actions on
immune cells in the gut, as they do not stimulate the proliferation of mononuclear cells or trigger an inflammatory action.
Regardless of whether the probiotics are used for human or animal consumption,
there are several characteristics that a probiotic must achieve.
Probiotic Characteristics
Some of the important characteristics of probiotics include the
following: a probiotic must be generally
required as safe (GRAS); a probiotic should exhibit bile and acid
tolerance to survive the path from the oral cavity to the small
intestine where it lives, multiplies and excretes beneficial nutrients and
molecules; a probiotic should have the ability to adhere to mucus and/or
epithelial cells, and/or other surfaces; a probiotic should be susceptible to
antibiotics; a probiotic should exhibit antimicrobial activity against
pathogens.
Homeostasis
Although it is accepted that probiotics must be of human origin, many
authors have found that some strains that are not normally isolated from humans have shown to be effective, which negates this requirement. As noted above, one
of the important attributes of probiotics is their antimicrobial effect against
pathogens by maintaining the
homeostasis of the intestinal flora. Assessing the antimicrobial effect
of various probiotics against pathogenic microorganisms is the guiding concept
of this chapter. This chapter reviews the principles and results from various
authors of different methods for determining the antimicrobial or antagonistic effect of probiotics against potential
pathogens.
Probiotic Immunology
Probiotic immunology refers to how beneficial microbes (probiotics) modulate and support the host's immune
system, particularly the gut-associated immune cells, to promote health
and fight disease. Probiotics can improve immunity by maintaining the gut
barrier, stimulating immune cell production (like macrophages and dendritic
cells), and secreting antimicrobial compounds. This interaction can lead to a balanced immune response,
offering potential benefits for various conditions, including infections,
allergies, and inflammatory diseases.
Probiotics Model Animal Systems
Probiotic animal model systems use diverse methods and host organisms,
including farm animals (like swine
and fish), companion animals (like dogs and cats), and even
human-derived cells and gnotobiotic
(germ-free) animals, to assess probiotic effectiveness by examining
their impact on the gut microbiome, immune response, nutrient absorption, and
growth performance. These systems evaluate how probiotics survive the
gastrointestinal (GI) tract and promote beneficial microbes, while also being
used to test their efficacy against challenges like pathogens or immune-related
conditions.
Commensal Microbes
Commensal microbes are microorganisms, predominantly bacteria, that
live on the surfaces of a host organism, such as the gut or skin, without causing harm or benefiting the
host in the traditional sense of the word "commensal".
However, emerging evidence suggests that many commensal communities engage in a
mutually beneficial (mutualistic) relationship with their hosts, aiding in
digestion, nutrient extraction, immune system development and function, and
protection against pathogens.
Gastrointestinal Tract (GIT)
The gastrointestinal tract (GIT), also known as the digestive tract or
alimentary canal, is a long, winding tube-like organ system in the human body
responsible for the digestion, absorption, and elimination of food. It extends
from the mouth to the anus and includes a series of interconnected organs.
Respiratory Tract
The respiratory tract is a system of organs and airways, including the
nose, throat, larynx, trachea, bronchi, and lungs, that allows for breathing and
gas exchange between the body and the external environment. Its functions include filtering
air, warming and humidifying inhaled air, and facilitating the exchange of
oxygen for carbon dioxide in the alveoli.
Fungi Revisited
Effects of a Novel Probiotic
Combination on Pathogenic Bacterial-Fungal Polymicrobial Biofilms - How do
probiotics affect pathogenic fungi (mBio)
https://mbio.asm.org/content/10/2/e00338-19
By CL Hager · 2019
Metabolites released by Lactobacillus species, such as sodium butyrate,
have been shown to inhibit biofilm formation, to potentiate the effect of
antifungal agents, and to suppress C. albicans filamentation, thereby reducing fungal pathogenicity.
C. albicans filamentation
Candida albicans filamentation is a key virulence factor where the yeast switches from round
budding cells to elongated, filamentous (hyphal) forms, a process triggered by
host-like conditions such as body temperature (37°C), neutral pH, serum, and
hormones. This morphogenesis is regulated by complex signaling pathways, including the cAMP/PKA pathway,
and is necessary for C. albicans to establish infections by allowing it to
invade host tissues and form biofilms.
Reducing Fungal Pathogenicity
Reducing fungal pathogenicity involves several strategies, including
using antifungal medications, maintaining good hygiene to prevent exposure and
spread, strengthening the immune system through probiotics or a healthy diet, and targeting specific fungal
virulence factors like biofilm formation or metabolic pathways. In agricultural
settings, approaches include developing disease-resistant crops and using
biological control agents to combat plant pathogens.
FAQ - Do probiotics fight fungus?
Probiotics as Antifungals in Mucosal
Candidiasis
https://academic.oup.com/cid/article/62/9/1143/1745140
Organisms of the genus Lactobacillus have been traditionally used as
probiotics for decades, and they are deemed worthy as an alternative biological approach to combat bacterial and
fungal pathogens in the oral cavity, GI tract, and urogenital system. Jan 29,
2016
Probiotic engineering: Towards
development of robust probiotic strains with enhanced functional properties and
for targeted control of enteric pathogens
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5422995/
FAQ - How do probiotics reduce the
pathogen growth?
During competition for nutrients, probiotics produce metabolites such
as volatile fatty acids, reducing the
pH of the GIT. The reduction in the pH of the GIT makes it an
unfriendly environment for pathogens and will thus lead to their inhibition because most of them cannot grow at
low pH. May 8, 2017
Mucosal Candidiasis
Mucosal candidiasis is a fungal infection of the mucous membranes, most
commonly caused by Candida albicans. It can affect various mucous surfaces, including the mouth, throat,
vagina, and intestines.
Genus Lactobacillus
What is the Lactobacillus genus?
Lactobacillus (genus Lactobacillus), any of a group of rod-shaped,
gram-positive, non-spore-forming bacteria of the family Lactobacillaceae.
Similar to other genera in the family, Lactobacillus are characterized by their
ability to produce lactic acid as a by-product of glucose metabolism. Sep 16,
2025
Bacterial and fungal pathogens in
the Respiratory Tract
Bacterial respiratory
pathogens include
Streptococcus pneumoniae, Staphylococcus aureus, Haemophilus influenzae, and
Klebsiella pneumoniae, causing infections like pneumonia, while fungal pathogens such as
Aspergillus, Candida, and Pneumocystis typically cause illness in
immunocompromised individuals. Fungi are often environmental and not
contagious, and can lead to serious lung infections like fungal pneumonia,
especially in patients with weakened immune systems.
Probiotics Displacement and the
pH Advantage
Probiotics displace pathogens by producing
lactic acid, lowering the pH, and creating an environment that's hostile
to harmful bacteria, like Gardnerella, but is ideal for beneficial bacteria
like Lactobacillus. This competitive
exclusion and the production of antimicrobial substances provide a pH
advantage by maintaining a healthy, stable microbiome, which is crucial for
preventing infections in the gut and vaginal environments.
Repurpose and expand upon Yakult.
Pressured Probiotic Metered
Inhaler (pPMI)
A Pressured "Probiotic Metered Inhaler" (pPMI) is not a current or approved medical device;
rather, it represents a hypothetical concept combining the delivery method of a
metered-dose inhaler (MDI) with the potential therapeutic benefits of
probiotics for respiratory conditions like asthma. While research explores
using specific probiotic strains to improve asthma control and reduce
exacerbations, existing treatments involve different delivery methods, and the
concept of an MDI for probiotics is still in the developmental and experimental stage.
Sources of Probiotics - Yakult
and Dannon
Yakult is a unique probiotic drink from Yakult Honsha
containing the L. paracasei strain Shirota, while Dannon's probiotic products,
like Activia, are primarily yogurt brands that feature their own proprietary strains, such as
Bifidobacterium animalis lactis DN-173 010. Both companies offer fermented
dairy-based products with live, beneficial bacteria to support digestive
health, but they differentiate
themselves through their specific strains and product formats.
Nasal Version
Test - Saline nasal spray unit
Probiotic Sources – Yakult and
Dannon
FYI - Yakult Ingredients -
Formulation
Probiotic(s)
In 2020, the bacteria strain historically known as Lactobacillus casei
Shirota was officially reclassified
as Lacticaseibacillus paracasei strain Shirota (LcS). The reclassification was
based on advanced genetic sequencing that revealed a more diverse microbial
world than previously understood. The new name reflects a greater understanding
of how the bacteria's genetic makeup relates to their ecological niche and
physiological function.
Lactobacillus casei Shirota
Probiotic Lactobacillus casei strain Shirota relieves stress-associated
symptoms by modulating the gut-brain interaction in human and animal models.
Lactobacillus paracasei
Is Lactobacillus casei the same as Lactobacillus paracasei?
The L. casei group, consisting of L. casei, L. paracasei, and L.
rhamnosus, is a commercially
important group of bacteria used as probiotics, but its taxonomic
classification remains complex due to genetic similarities among species.
Although these bacteria are genetically close, their classification is
inconsistent, with many strains misidentified or needing reclassification based
on advanced genomic analyses. This ongoing taxonomic
confusion complicates the functional understanding and application of
these important bacteria in food and health.
Does one refrigerate Yakult?
Yes, Yakult must be
refrigerated at temperatures below 10°C (50°F) to maintain the quality
and activity of its live probiotic bacteria, the Shirota strain. While it can
be left at room temperature for a short period (typically 4–8 hours) without
significant issues, leaving it out for longer or at high temperatures can cause
the bacteria to become less active, affect the product's taste, and reduce its
overall effectiveness.
Does one refrigerate metered
inhalers?
No, you generally do not
refrigerate metered inhalers;
they should be stored at room temperature, as extreme temperatures, including
cold, can affect their effectiveness and may prevent them from working
properly. It's best to keep them in a clean, dry place and follow the specific
storage instructions on the patient information leaflet that comes with your
inhaler.
Materials - Biological Material
Dannon DanActive
1. L.
bulgaricus
2. S.
thermophilus
3. L.
casei immunitus
Each bottle contains more than 10 billion of its live and active
probiotic, Lactobacillus casei Immunitas® (L. casei DN-114 001). This probiotic
survives and remains active in the digestive tract, where about 70% of your
immune system is located.
https://www.danactive.com/probiotic-dairy-drinks/vanilla/
Contains Live Cultures:
L. Bulgaricus & S.
Thermophilus
The statement "Contains Live Cultures: L. Bulgaricus & S.
Thermophilus" means the product, typically yogurt, contains living beneficial bacteria,
Lactobacillus bulgaricus and Streptococcus thermophilus, that are essential for
the fermentation process and provide probiotic benefits. These specific
bacteria help thicken milk and convert it into yogurt, while also aiding in the
digestion of lactose and offering potential health advantages.
Contains Live & Active
Probiotic:
L. Casei Immunitas®
(Lactobacillus Casei DN-114 001)
The phrase "Contains Live & Active Probiotic: L. Casei
Immunitas® (Lactobacillus Casei DN-114 001)" indicates the presence of a
specific live and active probiotic strain, L. Casei Immunitas®, identified as
Lactobacillus Casei DN-114 001, which is a type of Lactobacillus casei bacteria
used in products like DanActive. This strain is known for its ability to
survive in the gut and may offer benefits such as supporting the immune system
and helping to prevent conditions
like antibiotic-associated diarrhea.
Materials
Probiotics and Gut (GIT) Health
https://www.webmd.com/digestive-disorders/what-are-probiotics#:~:text=Probiotics%20are%20live%20bacteria%20and,help%20keep%20your%20gut%20healthy.
Probiotics are live bacteria and yeasts that are good for you,
especially your digestive system. We usually think of these as germs that cause
diseases. But your body is full of
bacteria, both good and bad. Probiotics are often called
"good" or "helpful" bacteria because they help keep your
gut healthy. Jul 30, 2020
Commercial-off-the-shelf
Probiotic Bacteria
Introduction (GIT = GI Tract)
https://consumerssurvey.org/lp/probiotics-b?tr=4nrXkDl&msclkid=27617ab4a3291acab2091aa4dd63f04f
5 Signs Your Gut Health Is In
Danger - Out of Scope
Will inhaled probiotics help with
gut problems?
No, probiotics are not inhaled to treat gut problems; they
are typically consumed orally. Inhaled probiotics show promise for respiratory
health by modulating the gut-lung
axis, which connects the two systems, but this is a distinct and emerging area of
research and not a direct treatment for gut issues.
How the Gut-Lung Axis Works
Connection: There is a
well-established communication pathway between your gut and your lungs, known
as the gut-lung axis. Microbial Influence: Microbes and their products in the
gut can influence the respiratory system, and vice versa. Probiotic Role: Inhaling probiotics may help with
respiratory diseases by optimizing the gut microbiota, which can strengthen the
respiratory tract's immune system.
Aside - GIT Problems - Digestive
Issues
Abdominal Pains
Bloating
Constipation
Cramps
Diarrhea
Food Poisoning
Gas
IBS
Upset Stomach
Interrelationship of Gut and Respiratory Health
The gut and respiratory systems are interconnected through the
"gut-lung axis," where the gut microbiome influences respiratory
health via circulating immune cells, metabolites, and cytokines. A healthy gut microbiome supports
a balanced immune response, enhances lung defenses, and can reduce
inflammation, while an unhealthy gut (dysbiosis) can increase susceptibility to
respiratory infections and conditions like asthma and COPD. For instance, gut
microbes produce beneficial short-chain fatty acids that travel to the lungs to reduce inflammation.
In Scope
Certain Allergies
Coughing
Flu
Sinus Congestion
The Common Cold
Weakened Immunity
Associated with GIT problems
"Senior Moments”
Brain Fog
Depression
Irritability
Mental Health
Mood Swings
Medication & GIT Problems
Medication use and gut health
Medication use significantly impacts the gut microbiome through direct
antimicrobial effects or by altering the gut environment, leading to changes in microbial composition and
function that can affect drug efficacy and host health. Common medications
such as antibiotics, proton pump inhibitors (PPIs), and selective serotonin
reuptake inhibitors (SSRIs) are known to cause lasting shifts in gut bacteria,
potentially increasing risks for infections and other health complications.
Patients can support their gut health by consuming
probiotics and fiber-rich foods, but they should always consult a
healthcare provider before stopping or changing prescribed medications.
Medication use and respiratory
tract health
Medication can both treat and impact respiratory health, with
treatments including antibiotics for bacterial infections and inhaled
medications for asthma and COPD, which reduce airway inflammation and
constriction. Conversely, some medications, like certain NSAIDs and
acetaminophen, can hinder respiratory health by triggering airway constriction
or reducing lung antioxidants. Therefore, judicious
use of medications for respiratory conditions is crucial to prevent
adverse effects, antibiotic resistance, and to manage symptoms
effectively.
Judicious Use
"Judicious use" means the application of good judgment,
common sense, and wisdom when using something, emphasizing careful, sensible,
and strategic application to achieve optimal results. It involves being
prudent, not wasting resources, and making well-advised
decisions, such as using limited funds or time wisely or applying a
technique strategically in a treatment.
Introduction – Ancillary
Improvements
Origins of Ideas
https://consumerssurvey.org/lp/probiotics-b?tr=4nrXkDl&msclkid=27617ab4a3291acab2091aa4dd63f04f
Skin Problems
1. Acne
2. Breakouts
3. Dry/Dull
Skin
4. Eczema
5. Psoriasis
6. Rosacea
7. Skin
Blemishes
Can lung health impact skin health?
Yes, lung health can significantly impact skin
health, affecting it through direct cancer spread to the skin, hormonal changes
from lung conditions, systemic inflammation, impaired oxygenation, or by
triggering autoimmune reactions. Conversely,
skin health can also reflect lung issues, with signs like bluish skin
from low oxygen, darkened skin patches from acanthosis nigricans, or symptoms
of allergic conditions like eczema, which can be associated with asthma.
Pressured Probiotic Metered
Inhaler (pPMI)
Spray - Preliminary Material List
Image of Materials
Materials and Methods - Inhaler
Generic - Inhaler Schematic – Pressurized
Probiotic Metered Inhaler (PMI)
Canisters and Actuators
http://www.globalasthmareport.org/2014/management/inhalers.php
http://www.globalasthmareport.org/2014/images/figures/Ch11_Fig1.jpg
Methods
Sub-contractor
>A sub-contractor familiar
with charging dose inhaler canisters will fill each canister with the liquid
phase formulation and the appropriate gas phase. We hope that each charged canister
has a shelf life of one (1) year or more.
The charged canisters may or may not need refrigeration. We would prefer no refrigeration.
Standards and Metered Systems
>A couple of years ago, Buster
suffered early-stage pneumonia. His
Teladoc doctor prescribed an antibiotic and an inhaler (Albuterol). After using the inhaler for the rescue stage, he set it aside for future prevention.
He still has some left. He took
for granted that the inhalers are precision and moderately complex devices. When the inhaler
product is delivered we recommend meeting the requirements and
specifications for inhalers such as asthma inhalers. There appear to be both World Health
Organization (WHO) and other international standards. We prefer the metered dose systems.
Proof of Concept
>Proof of Concept is challenging
because we have tried to prove the nasal spray concept on Buster, yet we have
been unable to reach an encompassing
conclusion. If push came to
shove, we would select the leghorn chicken model to determine efficacy and
safety. Birds have delicate respiratory
systems as compared to humans.
Challenging birds with respiratory pathogens can help determine product
protective value on humans. Some of the
pathogens to consider with birds are Avian Influenza, Coronaviruses, and Rhino
Viruses.
Inhaler
“The manufacture of asthma inhalers requires accuracy and reliability
so that their quality is assured for each dose, and from one inhaler to
another. Non-quality-assured asthma inhalers may be ineffective.” Quality Assurance needs to assess the number of live probiotic life
forms at any given time in the product life cycle. The products may require refrigeration.
Product Complexity
Recommendation - Standards
>Probiotics differ from dosing
than typical respiratory pharmaceuticals in that precision dosing is not
necessary. The active ingredients are
not intended to be absorbed. The
probiotics may have some rescue value, yet they are intended to be preventative in nature.
Inhalers Quality Standards
“The WHO should add essential asthma medicines to their
Prequalification Programme, promote the standardization of the dosages of
active ingredients in combined inhalers, and the harmonization of quality
requirements for inhalers across international reference documents such as the
pharmacopoeias. Governments in all countries should ensure all asthma inhalers
procured, distributed, and sold in their countries meet international quality standards.”
Promote the Inhaler
>We move past the nasal spray
idea. For the inhaler product, we
recommend referencing the standardized systems as models. The diagrams provided earlier are a good starting point. We emphasize the Inhaler because the nasal
spray exists in the marketplace.
Methods – Staffing Brief -
Revisited
·
Clinical Research Assistant
·
Product Engineer
·
Project Manager
Staffing - Clinical Researcher's
Assistant - Example
https://www.linkedin.com/in/claudiapolanowski?trk=public_profile_browsemap
https://www.linkedin.com/in/claudia-p-marketing-profile?trk=public_profile_samename-profile
FYI – Experience – Henkel (2013 –
2014 1 year 1 month)
·
1 year of experience constructing and executing science experiments
·
Product
application
·
Daily data
collections
·
Manage Excel
data sheets
·
Operate
lab equipment - testing appropriately
·
Organize
study procedures and policies
·
Record
data for antimicrobial procedures
·
Recruiting
panelists (Experimental Cohorts)
·
Executing
science experiments with microbes
·
Operate laboratory
machinery
·
Operate laboratory
equipment
Training and Certification
Training and certification in: Lab Safety, Personal Protective Equipment,
GHS: USA. Compliance, Eye Safety, GHS Chemical Labeling & Classification,
Hazard Recognition, and Biosafety
and Bloodborne Pathogens.
Yakult Product Engineer Skills
For a product engineer at Yakult, skills
combine general engineering competencies with specific knowledge of
microbiology, food science, and manufacturing in the probiotic beverage
industry. Key skills include product design, process optimization, and quality
assurance, as well as a strong understanding of food safety regulations.
Laboratory Equipment used at
Yakult
Yakult Laboratories use equipment for quality control, such as
microscopes and hemocytometers for examining bacterial cultures, refractometers
for measuring sugar content (Brix), density meters for specific gravity, and titration
equipment for measuring acidity. The manufacturing process also involves
specialized equipment like ultra heat sterilizers for killing unwanted
bacteria, automated filling and capping machines, and injection blow moulding
machines for producing Yakult's distinct bottles.
Materials
FYI – Inhaler Model
Christophe Perrin, Luis
García-Marcos, Javier Mallol, Karen Bissell
[COPY AND PASTE LINK –
ResearchGate requires a security check]
https://www.researchgate.net/figure/Schematic-of-the-3M-Autohaler-breath-actuated-inhaler-During-priming-a-spring-is_fig6_259394910
Summary
>Our Pressured Probiotic Metered
Inhaler (pPMI) addresses an unmet
need in the general human population.
Using Competitive Microbiologic Exclusion (CME), our pPMI will displace
pathogenic microbes and viruses (and fungi).
At this time, sharing our idea appears most feasible. During the fall of 2021, we sold this idea to
a trusted person with knowledge in pharmaceutical development and marketing. Quality of the pPMI shall be equal to or
better than COTs inhalers. The scope of
the product we outlined with diagrams.
The scope of the project roughly follows three stages. Stage one share, stage two development, and
stage three patents as needed.
How is it 4 years?
Why did it take 4 years to share the
product idea?
Multiple factors can lead to a delay in sharing a product idea for four
years, including the extensive time needed for product development, concerns
over protecting intellectual property,
and waiting for the optimal market timing. A
four-year timeline is not unusual in product development, especially
for complex products or those in emerging markets.
Results
Rough of Product Development
Cost – Benefit Breakdown (2021
LDC & 2025 ASK)
Aside - How to patent an idea?
To patent an idea, you must develop it into a concrete invention that is new, useful, and non-obvious;
then, conduct a thorough patent search to ensure it isn't already patented;
next, prepare a patent application, which can be a provisional (temporary) or
non-provisional (full) application; and finally, submit the application to the
United States Patent and Trademark Office (USPTO) and work with a patent
examiner to get approved.
Cost of bringing a probiotic to
market?
The cost of bringing a probiotic to market varies significantly,
ranging from under $10,000 for a basic
private-label dietary supplement to hundreds of millions for a new,
regulated drug. The total expense depends on whether the product is classified as a dietary
supplement or a regulated drug, as each path has different manufacturing,
testing, and regulatory requirements.
Colonizing your lungs after
antibiotic treatment
After antibiotic treatment, colonization of the lungs by harmful
bacteria can occur when antibiotics disrupt
the lung microbiome and allow antibiotic-resistant bacteria (ARBs) or
other pathogens to gain a foothold. This colonization, where bacteria are
present but not yet causing an active infection, increases the risk of
developing serious respiratory illnesses and can make treatment more
challenging. Risk factors include the type and length of antibiotic treatment,
as well as underlying conditions like chronic obstructive pulmonary disease
(COPD) or a compromised immune system.
Microbial Competitive Exclusion
Microbial competitive exclusion is a bio-protective mechanism where
beneficial microorganisms prevent pathogenic microbes from establishing by outcompeting them for resources
like nutrients and space, blocking attachment sites on host surfaces, or by
actively killing them with antimicrobial compounds. This process is crucial for
maintaining a healthy microbiome, such as in the gut, and can be enhanced
through the use of probiotics and fermented foods.
Promotion – Yakult
https://www.yakultusa.com/
Yakult is a sweetened, fermented, nonfat milk-based probiotic drink
created in Japan in 1935 by Dr. Minoru Shirota, containing billions of the live and active Lacticaseibacillus casei
Shirota strain bacteria. Named after the Esperanto word for "yogurt,"
it is a popular global beverage known for promoting gut health by increasing
beneficial bacteria in the digestive system. Yakult also offers products
fortified with Vitamin D and Vitamin C for immunity and to reduce fatigue.
FYI - What is Yakult?
Yakult is a sweetened, fermented probiotic dairy drink, created in
Japan in 1935 by Dr. Minoru Shirota. It contains billions of live, beneficial bacteria called
Lacticaseibacillus casei strain Shirota (LcS). This unique strain is
scientifically proven to survive gastric juices and bile to reach the gut,
where it is believed to improve digestion and boost the immune system.
Promote – One Health
https://www.who.int/health-topics/one-health#tab=tab_1
One Health is an approach calling for "the collaborative efforts
of multiple disciplines working locally, nationally, and globally, to attain optimal health for people,
animals, and our environment", as defined by the One Health
Initiative Task Force.
Promote – World Wafers – Work Done
https://healthman2059.blogspot.com/2025/08/world-wafers-for-addressing.html
FYI
- Appendix – Project Aspects
Project Life Cycle - Project
Management Methodology
Project Management Life Cycle
The MPMM™ Project Management Life
Cycle comprises...
Project Planning
Planning involves setting out the
roadmap for the project by creating the following plans:
|
Plan
|
|
Project Plan
|
|
Resource Plan
|
|
Financial Plan
|
|
Quality Plan
|
|
Acceptance Plan
|
|
Communications Plan
|
Project Plan
To plan a project, define its scope and objectives, identify
stakeholders, create a realistic schedule with milestones and tasks, assign
roles and responsibilities, allocate resources and budget, develop a
communication plan, and outline a risk management strategy. The resulting
project plan serves as a formal document to guide execution and control,
ensuring everyone understands the goals,
tasks, and timelines required to achieve the desired outcome.
Project Resource Plan
A project resource plan is a document that outlines the people, budget,
materials, and tools required to complete a project, detailing their allocation
and management throughout the project lifecycle. This strategic document ensures
that necessary resources are available at the right time and used efficiently
to achieve project goals on time and within budget. Key aspects include
identifying resource needs, assessing availability and skills, assigning tasks,
and monitoring usage to prevent
overspending, resource bottlenecks, and employee burnout.
Project Financial Plan
A project financial plan is a comprehensive roadmap detailing a
project's estimated costs, potential revenues, and funding strategy to ensure
financial viability and successful completion. Key elements include cost
estimation, budget creation, resource planning, financial forecasting, and
regular monitoring to manage expenses and track performance against financial
goals. Effective financial planning helps minimize
financial risks, control overruns, and allocate resources efficiently
throughout the project lifecycle.
Project Quality Plan
A Project Quality Plan (PQP), or quality management plan, is a document
that outlines a project's quality objectives, standards, procedures, and
responsibilities to ensure deliverables meet stakeholder expectations. It's a
proactive, continuous process
that includes quality planning, assurance, and control activities to embed
quality into all project phases and achieve successful outcomes by preventing
errors and satisfying customers.
Project Acceptance Plan
A Project Acceptance Plan is a formal agreement outlining the specific
criteria, processes, and responsibilities for client acceptance of project deliverables. It defines the
standards and conditions that must be met for the project's outputs to be
considered complete and satisfactory to stakeholders, ensuring clear
communication and successful project closure. Key components include acceptance
criteria, roles, timelines, and the process for addressing issues.
Project Communication Plan
A project communication plan is a document that defines what
information will be shared, to whom, when, how (channel), and by whom to ensure
all project stakeholders are aligned and informed. It establishes a standard operating procedure for
communication, helping to prevent miscommunication, manage expectations,
maintain clarity, and keep the project on track.
Project Life Cycle diagram
Initiation involves starting up the project, by
Project Initiation Phase
The project initiation phase is the first step in the project management lifecycle where a
project idea is formally defined, evaluated for feasibility, and justified
through a business case, leading to a decision on whether to approve the
project and allocate resources to start it. Key activities include developing
a business case, conducting feasibility studies, identifying stakeholders, and
creating a project charter to formalize the project's existence and gain approval from key
decision-makers.
Documenting a Business Case
To document a business case, you must provide an executive summary,
problem statement, project scope and objectives, detailed analysis of
alternative solutions with associated
costs and benefits, a financial appraisal including return on
investment (ROI), a risk assessment with mitigation plans, and an
implementation plan with a clear timeline and required resources. The document
should be clear, concise, data-backed, and tailored to its audience to ensure it
effectively communicates the
project's value and justifies the investment.
Project Feasibility Study
A project feasibility study is a comprehensive assessment of a proposed
project's viability, determining its practicality from various standpoints, including
technical, economic, market, and legal factors. Its purpose is to help
stakeholders decide if a project
should proceed, be redesigned, or be abandoned by identifying potential
issues, required resources, costs, benefits, and the overall likelihood of
success.
Project Terms of Reference
A Project Terms of Reference (ToR) is a document outlining a project's
purpose, scope, key objectives, deliverables, timeline, budget, and roles and
responsibilities of involved parties to ensure a common understanding among
stakeholders and guide the project's execution and completion. It serves as a foundational strategy document,
detailing what the project aims to achieve, how it will be carried out, and
what will be produced.
Project - Appointing the Team
To appoint a project team, first, define project goals and scope to
determine necessary skills and roles, then identify the required expertise,
including both technical and
behavioral competencies. Next, select individuals based on their
skills, ability to collaborate, and alignment with project objectives, ensuring
a balanced, cross-functional team. Finally, clearly define roles,
responsibilities, and expectations for each member, along with the project's
organizational structure, to ensure accountability and effective communication.
Setting Up a Project Office
To set up a project office (often called a Project Management Office or
PMO), start by defining its vision and objectives aligned with business goals,
then secure executive sponsorship and determine the PMO's scope and structure (supportive, controlling, or directive).
Next, develop standardized processes, select appropriate project management
methodologies and tools, build a skilled team, and implement a phased approach
to launch and continuously measure its success.
Project Plan – (2021 LDC &
2025 ASK)
|
Element
|
|
Pre-sell
|
|
Need & Unmet Need
|
|
Research
|
|
Feasibility
|
|
Time
|
|
Quality – Project
|
|
Quality – Product
|
|
Money Matters
|
|
People
|
|
Sell
|
|
Plan
|
|
Initiate - Execute
|
|
Develop
|
|
Accept
|
|
Close
|
|
Document and Share
|
|
Lessons Learned
|
|
Next Steps
|
Execution
Project execution is the phase where planned project work is performed,
transforming ideas into actual
deliverables while overseeing the management of scope, budget, quality,
risks, and issues to align with project goals. This is the active phase of the
project lifecycle where the project team implements strategies, allocates
resources, tracks progress, and ensures that the project stays on track to
achieve its objectives.
Closure
Yes, Project Closure formally concludes a project by winding down
activities, releasing staff and resources, handing over deliverables to the
customer, and documenting lessons learned through a post-implementation review.
This comprehensive final phase
ensures all project objectives are met, stakeholders are informed, and the team
gains valuable insights for future projects.
