CompletedNot Applicable

The Effects of a Postbiotic Supplement on Biomarkers of Gut Health

United States76 participantsStarted 2024-11-05

Plain-language summary

This study is a randomized, double-blind, two-arm, placebo-controlled trial of N=80 (40/arm) apparently healthy men and women between 18 and 65 years old to be recruited at a single investigational center in Northeast Ohio (i.e., The Center for Applied Health Sciences). This study will assess the effectiveness of a postbiotic supplement on various biomarkers of health. Consumption of this dietary supplement is not intended to diagnose, treat, cure, or prevent any disease. Participants will attend three in-person study visits. During Visit 1, participants will be screened for participation (i.e., medical history, routine blood work, background baseline diet). Over the next 4 weeks, participants will attend two in-person visits: \[visit 2 (week 0) and visit 3 (week 4)\] wherein assessments of gut function \[fecal microbiome diversity, short chain fatty acids (SCFA), and fecal butyrate\], serum butyrate, serum zonulin, salivary cortisol, and Gastrointestinal Symptom Rating Scale (GSRS) for gastrointestinal (GI) health, emotional states \[Depression, Anxiety and Stress Scale (DASS21)\], and quality of life (SF-36 questionnaire) will be assessed. Participants will also be provided home kits with instructions on how to collect stool and saliva samples on two separate occasions (i.e., visit 2, visit 3) during the study. • Comprehensive side effect profile/ adverse event monitoring will take place throughout the study duration. The study will be conducted following ICH-GCP guidelines to ensure participant safety and scientific integrity of the data.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Provide voluntary signed and dated informed consent. • Be in good health as determined by medical history and routine blood chemistries. Age between 18 and 65 years (inclusive). • Body Mass Index of 18.5-34.9 (inclusive). • Body weight of at least 110 pounds. • Normotensive (seated, resting systolic blood pressure \<140 mm Hg and diastolic blood pressure \< 90 mm Hg. If the first measurement is slightly elevated above these limits, the participant will be given a brief (5-minute) rest period, and two more measurements will be taken. The average of all three measurements will be used to determine eligibility. • Normal seated, resting heart rate (\<90 per minute). • Willing to duplicate their previous 24-hour diet, refrain from caffeine for 24 hours, abstain from exercise for 48 hours prior, and fast for 10 hours prior to each laboratory visit. • Participant agrees to maintain existing dietary and physical activity patterns throughout the study period. • Participant is willing and able to comply with the study protocol. • No medical history of gastrointestinal distress. • Avoidance of cultured and fermented foods such as yogurt, kefir, kombucha during the duration of the study. Exclusion Criteria: * Current use of prebiotics, probiotics, postbiotics, or antibiotics within the past 4 weeks or use of any dietary supplement that may confound the study or its endpoints. Current use of GLP-1 inhibitors. • Individuals that adhere to a vegan diet. …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Evaluate the change in fecal microbiome diversity.

Timeframe: Participants will complete up to 5-week study consisting from screening, randomization, and enrollment periods to the end of treatment at 4 weeks

Trial details

NCT IDNCT07527286

SponsorVerb Biotics LLC

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-04-26

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