Probiotics for Immune Surveillance

Overseen By Gitte S Jensen

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Natural Immune Systems Inc

Must not be taking: Anti-inflammatories, Antipsychotics

Disqualifiers: Major gastrointestinal surgery, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 4 weeks

24 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you do not take anti-inflammatory medications daily or antipsychotic medications like clozapine, Risperdal, Abilify, Zyprexa, or Seroquel. If you are on these medications, you may need to stop them to participate.

What data supports the effectiveness of the treatment Probiotic Agent for immune surveillance?

Probiotics have shown promise in improving gut health and immune function by balancing intestinal bacteria and reducing inflammation. They have been effective in treating gastrointestinal issues like diarrhea and inflammatory bowel disease, suggesting potential benefits for immune-related conditions. ^{1 2 3 4 5}

Are probiotics generally safe for human use?

Probiotics have been used safely for many years, and most studies suggest they are generally safe for most people. However, there are some theoretical risks, especially for vulnerable groups like those with weakened immune systems, and more research is needed to fully understand these risks. ^{6 7 8 9 10}

How does the Probiotic Agent treatment differ from other treatments for immune surveillance?

The Probiotic Agent treatment is unique because it uses 'friendly bacteria' to enhance the body's immune response by interacting with the gut's natural microflora. Unlike traditional treatments, it modulates the immune system by influencing signaling pathways and immune cell activation, potentially offering a natural way to boost immune defenses against pathogens. ^{11 12 13 14 15}

What is the purpose of this trial?

Clinical proof-of-concept study, comparing the acute immune impacts of 3 doses of a probiotic strain to a placebo. This study involves twenty-four participants, composed of healthy adults, who will be taking a placebo and 3 different doses of the probiotic at different times. Testing for immune status and cytokine levels will be conducted to determine the acute impact of the probiotic on immune function when compared to a placebo.

Eligibility Criteria

This trial is for healthy adults interested in how a probiotic strain affects the immune system. Participants will be given either the probiotic or a placebo to compare their body's acute immune response.

Inclusion Criteria

I am a healthy adult.

My veins are visible and accessible in my arms.

Willing to comply with study procedures, including maintaining a consistent diet and lifestyle routine throughout the study, having a consistent habit of bland breakfasts on days of clinic visits, abstaining from exercising and nutritional supplements on the morning of a study visit, abstaining from use of coffee, tea, and soft drinks for at least one hour prior to a clinic visit, abstaining from music, candy, gum, computer/cell phone use, during clinic visits.

Exclusion Criteria

I have not had major surgery on my digestive system.

I take anti-inflammatory medications every day.

Having an unusual sleep routine (examples: working graveyard shift, irregular routine with frequent late nights, studying, partying)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive placebo and 3 different doses of the probiotic, each separated by a 1-week washout period

4 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

Treatment Details

Interventions

• Probiotic Agent

Trial Overview The study tests the immediate effects of three different doses of a probiotic agent on immune function, by measuring participants' immune status and cytokine levels against those taking a placebo.

Participant Groups

Group I: Experimental Group A Experimental Treatment 1 Intervention

Crossover study: Participants will be consuming placebo on the first clinic visit, a low dose of the probiotic on the second clinic visit, a medium dose of the probiotic on the third clinic visit, and a high dose of the probiotic on the fourth clinic visit. Each clinic visit is separated by at least 1 week wash-out period.

Who Is Running the Clinical Trial?

Natural Immune Systems Inc

Lead Sponsor

Trials

20

Recruited

510+

Jeneil Biotech Inc.

Collaborator

Trials

1

Recruited

20+

Findings from Research

Current evidence from well-designed, double-blind controlled trials does not strongly support the use of probiotics for treating gastrointestinal infections, with the exception of some data on rotavirus infections in children.

Probiotics may have potential therapeutic roles in treating inflammatory bowel diseases, suggesting that their mechanisms of action could be beneficial in specific gastrointestinal conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Probiotics in infective diarrhoea and inflammatory bowel diseases. Gionchetti, P., Rizzello, F., Venturi, A., et al.[2022]

Probiotic therapy, which involves using live non-pathogenic bacteria, shows promise in treating and preventing gastrointestinal disorders such as inflammatory bowel disease and antibiotic-related diarrhea, highlighting its potential efficacy in restoring gut health.

The therapeutic effects of probiotics may stem from their ability to compete with harmful pathogens, produce antimicrobial substances, and modulate immune functions, but further controlled clinical trials are needed to confirm these benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Probiotics: an emerging therapy. O'Sullivan, GC., Kelly, P., O'Halloran, S., et al.[2019]

Probiotics, particularly Lactobacillus species like Lactobacillus reuteri and Lactobacillus brevi CD2, show promise as safe adjuvant treatments for patients at risk of mucositis, especially in cases related to anticancer therapies and peri-implant mucositis.

While current studies indicate positive effects of probiotics, no single formulation has been strongly recommended due to the lack of clear high-risk patterns and the need for further research to optimize their use in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Probiotics and mucositis. Cereda, E., Caraccia, M., Caccialanza, R.[2022]

Probiotics, which are beneficial bacteria, can improve gut health by balancing intestinal microflora and reducing inflammation, and they are recognized as safe for consumption.

Recent research highlights the potential of genetically engineered Lactobacillus strains for use in oral immunotherapy, suggesting that probiotics could play a role in vaccination and delivering immune-regulating substances.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Probiotics: Isolated bacteria strain or mixtures of different strains? Two different approaches in the use of probiotics as therapeutics. Karimi, O., Pena, AS.[2019]

Probiotics have shown efficacy in reducing diarrhea, supported by recent meta-analyses, making this one of their best-documented benefits.

In cases of inflammatory bowel disease, high doses and combinations of different probiotic strains (like lactobacilli and bifidobacteria) are more effective in reducing inflammation and maintaining remission than single strains.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Probiotics as a treatment strategy for gastrointestinal diseases? Bergonzelli, GE., Blum, S., Brussow, H., et al.[2007]

Probiotics have a long history of safe use, and while clinical trials generally show no increased risk, the current literature lacks comprehensive safety reporting, making it difficult to draw definitive conclusions about their safety in intervention studies.

Theoretical risks associated with probiotics include systemic infections and gastrointestinal side effects, highlighting the need for further research to accurately assess the incidence and severity of any adverse events related to their use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk and safety of probiotics. Doron, S., Snydman, DR.[2022]

Probiotics can have both benefits and potential adverse effects, especially as their use expands into vulnerable populations, highlighting the need for careful monitoring and recommendations for safe use.

The International Scientific Association for Probiotics and Prebiotics emphasizes the importance of whole genome sequencing to assess the safety of probiotic strains, including their virulence and antibiotic resistance, to ensure product quality and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emerging issues in probiotic safety: 2023 perspectives. Merenstein, D., Pot, B., Leyer, G., et al.[2023]

Probiotic safety is influenced by factors such as the specific microbe used, the dose and duration of consumption, and the vulnerability of the consumer, highlighting the need for careful consideration in their use.

While probiotics have a long history of safe use in foods, there are potential risks, including infectivity and antibiotic resistance, which necessitate further research to fully understand their mechanisms and ensure safety, especially in vulnerable populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety assessment of probiotics for human use. Sanders, ME., Akkermans, LM., Haller, D., et al.[2022]

Probiotics are generally accepted as safe dietary supplements, but emerging evidence suggests potential risks, particularly for immunocompromised individuals, highlighting the need for thorough safety evaluations.

Future safety studies should integrate advanced genomic technologies with traditional phenotypic tests to ensure the selection of safe probiotic strains, as safety can vary significantly based on the specific strain, host, and dosage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emerging pre-clinical safety assessments for potential probiotic strains: a review. Haranahalli Nataraj, B., Behare, PV., Yadav, H., et al.[2023]

A systematic review of 57 clinical studies found that probiotics and synbiotics are safe for immune-compromised adults, with no serious adverse events linked to these products, indicating they are well tolerated.

Probiotics and synbiotics resulted in fewer adverse events compared to control groups, but the study highlighted issues with inconsistent reporting of adverse events, suggesting a need for standardized reporting to enhance data reliability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The administration of probiotics and synbiotics in immune compromised adults: is it safe? Van den Nieuwboer, M., Brummer, RJ., Guarner, F., et al.[2014]

Probiotics, often referred to as 'friendly bacteria', have been shown to improve gut health by interacting with the body's existing microflora, providing benefits such as preventing antibiotic-associated diarrhea and aiding in the remission of inflammatory bowel disease.

The positive effects of probiotics are largely due to their ability to produce antimicrobial substances and enhance the intestinal barrier, as well as stimulate immune responses, although the exact molecular mechanisms behind these benefits are still being researched.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Probiotics and small bowel mucosa: Molecular aspects of their interactions. Saulnier, N., Zocco, MA., Di Caro, S., et al.[2020]

Probiotic bacteria can significantly influence the immune system by either activating or suppressing immune responses, which helps maintain balance in the body and can affect inflammation and immune-related diseases.

Research shows that probiotics can modulate innate immune responses through various mechanisms, such as altering receptor activity and expression, which could lead to targeted therapies for both healthy individuals and those with inflammatory conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Probiotic Modulation of Innate Cell Pathogen Sensing and Signaling Events. Llewellyn, A., Foey, A.[2018]

Probiotic lactic acid bacteria can effectively signal the immune system, leading to enhanced local and systemic immune responses, which may help in fighting infections and diseases.

There is growing evidence that these probiotics can be used in immunotherapy for anti-tumor and anti-allergy treatments, as well as in boosting the body's resistance to microbial pathogens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microbes versus microbes: immune signals generated by probiotic lactobacilli and their role in protection against microbial pathogens. Cross, ML.[2022]

In a study involving milk-hypersensitive and healthy adults, the probiotic Lactobacillus GG was found to prevent an increase in immune receptor expression in hypersensitive individuals after a milk challenge, suggesting it may help reduce allergic responses.

Conversely, in healthy subjects, Lactobacillus GG enhanced the expression of immune receptors following the milk challenge, indicating a potential immunostimulatory effect that differs significantly between healthy and hypersensitive individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Probiotic bacteria down-regulate the milk-induced inflammatory response in milk-hypersensitive subjects but have an immunostimulatory effect in healthy subjects. Pelto, L., Isolauri, E., Lilius, EM., et al.[2021]

Probiotics can effectively modulate the mucosa-associated immune system, influencing dendritic cell activation and T cell responses, which is crucial for maintaining mucosal health and preventing diseases.

Specific probiotic strains, such as Lactobacillus acidophilus and Lactobacillus rhamnosus GG, can polarize immune responses towards different T helper cell types (Th1, Th2, Th17), suggesting tailored probiotic therapies could be developed for various immunopathologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mucosal immunology and probiotics. Dongarrà, ML., Rizzello, V., Muccio, L., et al.[2022]

References

1. Australia pubmed.ncbi.nlm.nih.gov

Probiotics in infective diarrhoea and inflammatory bowel diseases. [2022]

2. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Probiotics: an emerging therapy. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Probiotics and mucositis. [2022]

4. Spain pubmed.ncbi.nlm.nih.gov

Probiotics: Isolated bacteria strain or mixtures of different strains? Two different approaches in the use of probiotics as therapeutics. [2019]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Probiotics as a treatment strategy for gastrointestinal diseases? [2007]

6. United States pubmed.ncbi.nlm.nih.gov

Risk and safety of probiotics. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Emerging issues in probiotic safety: 2023 perspectives. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Safety assessment of probiotics for human use. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Emerging pre-clinical safety assessments for potential probiotic strains: a review. [2023]

10. Netherlands pubmed.ncbi.nlm.nih.gov

The administration of probiotics and synbiotics in immune compromised adults: is it safe? [2014]

11. Germany pubmed.ncbi.nlm.nih.gov

Probiotics and small bowel mucosa: Molecular aspects of their interactions. [2020]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Probiotic Modulation of Innate Cell Pathogen Sensing and Signaling Events. [2018]

13. England pubmed.ncbi.nlm.nih.gov

Microbes versus microbes: immune signals generated by probiotic lactobacilli and their role in protection against microbial pathogens. [2022]

14. England pubmed.ncbi.nlm.nih.gov

Probiotic bacteria down-regulate the milk-induced inflammatory response in milk-hypersensitive subjects but have an immunostimulatory effect in healthy subjects. [2021]

15. United States pubmed.ncbi.nlm.nih.gov

Mucosal immunology and probiotics. [2022]