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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess how different doses of a probiotic affect the immune system compared to a placebo. Participants will receive a placebo and three different probiotic doses over separate visits. The study focuses on changes in immune function and specific proteins called cytokines, which play a crucial role in the immune response. Individuals who are generally healthy and have easily visible veins for blood tests may be suitable candidates. Participants should maintain a consistent diet and lifestyle during the study, including consuming bland breakfasts on clinic visit days. As an unphased trial, this study provides participants the opportunity to contribute to groundbreaking research on probiotics and immune health.

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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that probiotics are generally safe for people, though some concerns exist. In rare cases, probiotics can cause issues like infections or toxic reactions, typically in individuals with specific health conditions.

One study examined unexpected problems from probiotics and found these issues to be uncommon and usually mild. This suggests that most people can use probiotics without difficulty.

In this study, participants will try different amounts of the probiotic to observe its effects on the immune system compared to a placebo. Evidence indicates that probiotics rarely cause serious side effects in humans. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this probiotic treatment because it offers a novel approach to enhancing immune surveillance, potentially providing a boost to the immune system. Unlike traditional treatments that might include medications or therapies targeting specific pathogens, probiotics work by promoting a healthy gut microbiome, which plays a crucial role in overall immune function. This treatment is particularly intriguing because it aims to naturally strengthen the body's defenses by leveraging beneficial bacteria, offering a potentially safer and more holistic alternative to conventional immune support methods.

What evidence suggests that this probiotic agent might be an effective treatment for immune function?

Research has shown that probiotics can positively affect the immune system. Studies have found that probiotics can alter the balance of gut bacteria, potentially enhancing immune function. For instance, probiotics have been linked to improved immune responses in conditions like allergies, eczema, and viral infections. In healthy adults, regular probiotic intake has improved both gut health and immune function. Overall, probiotics appear promising for boosting immune function, making them an interesting option for immune health benefits.

In this trial, participants will receive different dosages of a probiotic agent to evaluate its effects on immune surveillance. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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.

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

Unwilling to maintain a constant intake of supplements over the duration of the study

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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 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, 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]

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]

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, 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9818925/

Probiotics Mechanism of Action on Immune Cells and ... Experimental data obtained in vivo reported that specific probiotic bacteria may provide benefits in host immune homeostasis and immune function, while ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0753332222015840

The effect of probiotics on immune responses and their ... Studies show that probiotics can alter the gut microbiome, thereby improving and affecting the immune system and inflammatory responses in patients with MS.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4006993/

Probiotics and immune health - PMC Probiotics showed therapeutic potential for diseases, including several immune response-related diseases, such as allergy, eczema, viral infection, and ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT01479543

Effects of Probiotics in Immune System of Healthy Adults The regular intake has positive effects on the gastrointestinal and immune system.

5. frontiersin.org frontiersin.org/journals/immunology/articles/10.3389/fimmu.2023.1280680/full

Overview of anti-viral effects of probiotics via immune cells ... This comprehensive review examined the medical impact of clinically proven probiotics on infectious diseases, considering three crucial time periods.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3023597/

Safety assessment of probiotics for human use - PMC The safety of probiotics is tied to their intended use, which includes consideration of potential vulnerability of the consumer or patient, dose and duration ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0273230022001532

Considerations for determining safety of probiotics: A USP ... A safety assessment must consider the potential for a probiotic to express any virulence or toxin genes, which could lead to disease. Typically, the approach to ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12106448/

A pharmacovigilance study on probiotic preparations based ... This study aims to analysis adverse events (AE) related to probiotics from the FAERS database from the first quarter (Q1) of 2005 to the fourth quarter (Q4) of ...

9. academic.oup.com academic.oup.com/cid/article/46/Supplement_2/S104/276784?sub_id=ALESSANDRORIVALE

Safety of Probiotics | Clinical Infectious Diseases There are 3 theoretical concerns regarding the safety of probiotics: (1) the occurrence of disease, such as bacteremia or endocarditis; (2) toxic or metabolic ...

10. clinicaltrials.gov clinicaltrials.gov/study/NCT06754228?term=immune%20design&viewType=Table&rank=6

Acute Immune Modulation by Probiotic Strain 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.