45 Participants Needed

Prebiotic and Probiotic Supplement for General Health

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.12345

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.678910

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.23111213

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
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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.
See 11 more

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
2Treatment groups
Active Control
Placebo Group
Group I: Dietary Supplement with activesActive Control1 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: PlaceboPlacebo Group1 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.

Find a Clinic Near You

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

References

Nutritional impact of pre- and probiotics as protective gastrointestinal organisms. [2006]
[Pre- and probiotics]. [2015]
Prebiotics and probiotics: their role in the management of gastrointestinal disorders in adults. [2022]
I.31, a new combination of probiotics, improves irritable bowel syndrome-related quality of life. [2022]
Prebiotics: preferential substrates for specific germs? [2018]
Are Probiotics and Prebiotics Safe for Use during Pregnancy and Lactation? A Systematic Review and Meta-Analysis. [2021]
Novel and emerging prebiotics: Advances and opportunities. [2021]
Supplementation of infant formula with probiotics and/or prebiotics: a systematic review and comment by the ESPGHAN committee on nutrition. [2022]
Emerging issues in probiotic safety: 2023 perspectives. [2023]
10.United Statespubmed.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]
[Probiotics--an alternative for antibiotics?]. [2015]
Evaluation in human volunteers of the potential anticarcinogenic activities of novel nutritional concepts: prebiotics, probiotics and synbiotics (the SYNCAN project QLK1-1999-00346). [2007]
Human studies with probiotics and prebiotics: clinical implications. [2017]
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