Prebiotic and Probiotic Supplement for General Health

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Olly, PBC

Must not be taking: Probiotics, Antibiotics, Supplements, others

Disqualifiers: Severe digestive issues, Chronic conditions, Cancer, others

Compensation: Varies

Number of Visits: Unknown

Duration: 10 weeks

45 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

Yes, you will need to stop taking any medications and dietary supplements to participate in this trial.

What evidence supports the effectiveness of the prebiotic and probiotic treatment for general health?

Research suggests that prebiotics and probiotics can help maintain a healthy gut by promoting the growth of beneficial bacteria and inhibiting harmful ones. They have shown potential benefits in managing conditions like diarrhea, irritable bowel syndrome, and some inflammatory bowel diseases, although more human studies are needed to confirm these effects. ^{1 2 3 4 5}

Is the prebiotic and probiotic supplement generally safe for humans?

Research shows that prebiotic and probiotic supplements are generally safe for humans, including during pregnancy and lactation, with no serious health concerns reported. Some minor effects like changes in stool consistency have been noted, but overall, they are considered safe for general use. ^{6 7 8 9 10}

How does the prebiotic and probiotic supplement treatment differ from other treatments for general health?

This treatment is unique because it combines prebiotics and probiotics to support gut health by promoting the growth of beneficial bacteria and inhibiting harmful ones, potentially offering benefits for both gastrointestinal and systemic health. Unlike traditional treatments, this approach focuses on enhancing the natural balance of gut microbiota, which may have broader health implications beyond just treating specific conditions. ^{2 3 11 12 13}

What is the purpose of this trial?

Randomized, Crossover, Double-Blind, Placebo-Controlled, Single-Center Clinical Study with Daily Food Log, Stool Samples, Blood Draws, and Validated Questionnaires (GSRS, Bristol stool chart, and DQLQ) with Oral Dietary Supplement

Eligibility Criteria

This trial is for healthy individuals who are willing to take a dietary supplement or placebo, keep a daily food log, provide stool samples and blood draws, and complete certain health questionnaires.

Inclusion Criteria

I agree not to take any supplements or medications during the study.

I agree to give blood samples and collect stool samples as directed.

Subject has signed a written Informed Consent and is willing and able to attend all visits and comply with study instructions

Exclusion Criteria

I am on medication for a long-term health condition.

Subject is pregnant, nursing, or planning to become pregnant

I am currently taking dietary supplements, vitamins, or medications.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the active dietary supplement or placebo in a crossover design, with daily food logs, stool samples, blood draws, and validated questionnaires

10 weeks

Weekly visits for assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Dietary Supplement with actives

Trial Overview The study tests the effects of a prebiotic and probiotic supplement compared to a placebo. It's designed as a randomized, crossover trial where participants will switch between treatments.

Participant Groups

Group I: Dietary Supplement with actives Active Control 1 Intervention

Oral dietary supplement. Instructions: Instructions: Take 1 gummy per day with or without food or water. Do not take more than 1 gummy per day.

Group II: Placebo Placebo Group 1 Intervention

Oral dietary supplement. Instructions: Take 1 gummy per day with or without food or water. Do not take more than 1 gummy per day.

Who Is Running the Clinical Trial?

Olly, PBC

Lead Sponsor

Trials

4

Recruited

260+

Findings from Research

Pre- and probiotics can positively change the gut microbiome, which may enhance the host's health by improving immune function and lipid metabolism, as well as potentially preventing certain diseases like cancer.

The review highlights both supportive and opposing evidence regarding the effectiveness of pre- and probiotics in treating various conditions, including diarrhea, Helicobacter pylori infections, and inflammatory bowel disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional impact of pre- and probiotics as protective gastrointestinal organisms. Teitelbaum, JE., Walker, WA.[2006]

Pre- and probiotics have shown promising effects on gut health by maintaining a healthy gut microflora and influencing metabolic and immune mechanisms, but scientific proof of their benefits in humans is still lacking.

Certain clinical conditions, such as ulcerative colitis and antibiotic-induced diarrhea, have demonstrated therapeutic benefits from pre- and probiotics, suggesting potential for broader applications in gut health management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Pre- and probiotics]. Meier, R., Lochs, H.[2015]

Probiotics and prebiotics have been traditionally consumed for their health benefits, particularly for gut health, and there is growing scientific interest in the gut microbiota's role in health and disease.

While some human diseases, such as diarrheal illnesses and inflammatory bowel diseases, may benefit from probiotics, there is still a lack of extensive clinical evidence supporting their use, especially for prebiotics, which have not been widely tested in large-scale trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prebiotics and probiotics: their role in the management of gastrointestinal disorders in adults. Quigley, EM.[2022]

In a clinical trial with 84 patients suffering from irritable bowel syndrome (IBS), a novel probiotic combination (I.31) significantly improved IBS-related quality of life compared to a placebo, with notable increases in scores after 6 weeks of treatment.

Both high and low doses of the probiotic led to greater improvements in gut-specific anxiety and quality of life, with no reported adverse effects, indicating that I.31 is a safe and effective option for managing IBS symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

I.31, a new combination of probiotics, improves irritable bowel syndrome-related quality of life. Lorenzo-Zúñiga, V., Llop, E., Suárez, C., et al.[2022]

Prebiotics, particularly inulin-type fructans, are non-digestible ingredients that can selectively promote the growth of beneficial gut bacteria, which may improve health outcomes.

To truly understand the prebiotic effects, it's essential to study their impact on the entire gut microbiota in human subjects, rather than just focusing on individual bacteria in isolation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prebiotics: preferential substrates for specific germs? Roberfroid, MB.[2018]

A systematic review of 11 studies found that probiotic and prebiotic supplementation during pregnancy and lactation is generally safe, with only minor adverse effects reported.

The most notable adverse effect was an increased risk of vaginal discharge and changes in stool consistency associated with specific strains, but these do not pose serious health concerns for mothers or infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are Probiotics and Prebiotics Safe for Use during Pregnancy and Lactation? A Systematic Review and Meta-Analysis. Sheyholislami, H., Connor, KL.[2021]

Prebiotics, which are non-digestible carbohydrates, have various health benefits for both humans and animals, including positive effects on the gastrointestinal tract, cardiometabolism, and mental health.

There is a significant regulatory challenge regarding prebiotics, as clear definitions and classifications are needed to help consumers and manufacturers understand their benefits and applications, especially for emerging and non-established prebiotics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel and emerging prebiotics: Advances and opportunities. Cardoso, BB., Amorim, C., Silvério, SC., et al.[2021]

Current evidence suggests that probiotic- and/or prebiotic-supplemented infant formulae do not raise safety concerns regarding growth or adverse effects in healthy infants, based on a systematic review of existing studies.

However, there is insufficient data to recommend routine use of these supplemented formulae, highlighting the need for well-designed randomized controlled trials to better understand their long-term safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supplementation of infant formula with probiotics and/or prebiotics: a systematic review and comment by the ESPGHAN committee on nutrition. Braegger, C., Chmielewska, A., Decsi, T., et al.[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]

In a trial with 15 healthy volunteers, a 4-week synbiotic intervention combining specific probiotics and chicory-derived inulin showed no adverse effects, indicating its safety for consumption.

The intervention led to an increase in the abundance of beneficial gut bacteria, particularly Bifidobacteriaceae, while the overall diversity of the gut microbiome remained unchanged, suggesting targeted effects of the synbiotics on gut health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Synbiotic Intervention with Lactobacilli, Bifidobacteria, and Inulin in Healthy Volunteers Increases the Abundance of Bifidobacteria but Does Not Alter Microbial Diversity. Rubin, IMC., Mollerup, S., Broholm, C., et al.[2023]

Probiotics are beneficial microbial supplements that help improve gut health by balancing intestinal bacteria, and they can be effective in treating conditions like lactose intolerance and various types of diarrhea, including those caused by antibiotics and infections.

Clinical studies indicate that probiotics may also enhance immune function, prevent allergic diseases, and help manage inflammatory bowel diseases, suggesting their potential role in overall health and disease prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Probiotics--an alternative for antibiotics?]. Trafalska, E., Grzybowska, K.[2015]

Prebiotics and probiotics can work together, known as synbiotics, to reduce cancer processes, particularly in the colon, which is a major health concern in aging populations.

The SYNCAN project aims to explore how synbiotics and prebiotics can be incorporated into food products without negatively affecting taste or quality, potentially enhancing our diets with beneficial nutrients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation in human volunteers of the potential anticarcinogenic activities of novel nutritional concepts: prebiotics, probiotics and synbiotics (the SYNCAN project QLK1-1999-00346). Van Loo, J., Jonkers, N.[2007]

Probiotics have been shown to effectively prevent and manage both gastrointestinal and non-gastrointestinal conditions by interacting with gut-associated lymphoid tissue (GALT) and modulating the immune response.

Recent human clinical trials suggest that prebiotics may also provide clinical benefits as dietary supplements, potentially offering new nutritional strategies for managing various gastrointestinal and systemic health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human studies with probiotics and prebiotics: clinical implications. Saavedra, JM., Tschernia, A.[2017]

References

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

Nutritional impact of pre- and probiotics as protective gastrointestinal organisms. [2006]

2. Switzerland pubmed.ncbi.nlm.nih.gov

[Pre- and probiotics]. [2015]

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

Prebiotics and probiotics: their role in the management of gastrointestinal disorders in adults. [2022]

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

I.31, a new combination of probiotics, improves irritable bowel syndrome-related quality of life. [2022]

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

Prebiotics: preferential substrates for specific germs? [2018]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Are Probiotics and Prebiotics Safe for Use during Pregnancy and Lactation? A Systematic Review and Meta-Analysis. [2021]

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

Novel and emerging prebiotics: Advances and opportunities. [2021]

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

Supplementation of infant formula with probiotics and/or prebiotics: a systematic review and comment by the ESPGHAN committee on nutrition. [2022]

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

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

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

Synbiotic Intervention with Lactobacilli, Bifidobacteria, and Inulin in Healthy Volunteers Increases the Abundance of Bifidobacteria but Does Not Alter Microbial Diversity. [2023]

11. Poland pubmed.ncbi.nlm.nih.gov

[Probiotics--an alternative for antibiotics?]. [2015]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Evaluation in human volunteers of the potential anticarcinogenic activities of novel nutritional concepts: prebiotics, probiotics and synbiotics (the SYNCAN project QLK1-1999-00346). [2007]

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

Human studies with probiotics and prebiotics: clinical implications. [2017]