CompletedNot Applicable

To Assess the Effect of Collagen on Gastrointestinal Discomfort in Healthy Adults With Gastrointestinal Symptoms.

Canada116 participantsStarted 2025-05-08

Plain-language summary

This study will enroll healthy adults with perceived gastrointestinal symptoms to evaluate the effect of collagen peptides compared to placebo.

Who can participate

Age range

18 Years – 64 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

. Healthy adults from 18 to 64 years of age (inclusive).
. Have a BMI between 18.0 to 34.9 kg/m2 (inclusive).
. In good general health as determined by the investigator.
. Are able to consume an animal-sourced powder product when mixed with water and taken orally.
. Have a presence of GI symptoms as confirmed by a GSRS average score between 2 and 5 (inclusive).
. Have maintained consistent dietary habits, including medication and supplement intake, and lifestyle for the last 3 months before screening and agree to maintain them throughout the study.
. Agree to avoid anal penetration for 72 h prior to each fecal sample collection.
. Agree to follow the restrictions on concomitant treatments, and lifestyle.

Exclusion criteria

. Individuals who are lactating, pregnant or planning to become pregnant during the study.
. Have a known sensitivity, intolerability, or allergy to any of the study products or their excipients.

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

To assess the impact of the Test Product on perceived GI discomfort in healthy adults compared to a placebo

Timeframe: Baseline to Week 8

Trial details

NCT IDNCT06937801

SponsorRousselot BVBA

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-11-21

View on ClinicalTrials.gov More Gastrointestinal Disorders trials