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.

Age range18 Years – 64 Years

SexALL

See this in plain English?

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

✓. 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.

✕. 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.
✕. Current COVID-19 infections, or currently have the post COVID-19 condition as defined by World Health Organization (WHO).
✕. Recent history of an episode of acute GI illness such as nausea, vomiting, or diarrhea.
✕. Have Type I diabetes, uncontrolled Type II diabetes, uncontrolled high blood pressure (≥140 systolic or ≥90 diastolic mmHg), or uncontrolled thyroid disease ("uncontrolled" defined as being unmedicated, have an unstable use of medication within 3 months prior to screening, or have a stable use of medication for 3 months but still have uncontrolled conditions).
✕. Have a current diagnosis or history of irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), functional constipation or diarrhea (defined by the ROME IV diagnostic criteria), celiac disease, malabsorption, gastroparesis, endometriosis or eating disorder.
✕. Have a chronic inflammatory condition/disease (e.g., rheumatoid arthritis, ulcerative colitis, lupus).
✕. Have medical condition(s) known to interfere with absorption, distribution, metabolism, or excretion of the study product (e.g., Crohn's disease, short bowel, acute or chronic pancreatitis, or pancreatic insufficiency).

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

Timeframe: Baseline to Week 8

NCT IDNCT06937801

SponsorRousselot BVBA

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-11-21

Who can participate

Age range18 Years – 64 Years

SexALL

See this in plain English?

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

✓. 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.

✕. 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.
✕. Current COVID-19 infections, or currently have the post COVID-19 condition as defined by World Health Organization (WHO).
✕. Recent history of an episode of acute GI illness such as nausea, vomiting, or diarrhea.
✕. Have Type I diabetes, uncontrolled Type II diabetes, uncontrolled high blood pressure (≥140 systolic or ≥90 diastolic mmHg), or uncontrolled thyroid disease ("uncontrolled" defined as being unmedicated, have an unstable use of medication within 3 months prior to screening, or have a stable use of medication for 3 months but still have uncontrolled conditions).
✕. Have a current diagnosis or history of irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), functional constipation or diarrhea (defined by the ROME IV diagnostic criteria), celiac disease, malabsorption, gastroparesis, endometriosis or eating disorder.
✕. Have a chronic inflammatory condition/disease (e.g., rheumatoid arthritis, ulcerative colitis, lupus).
✕. Have medical condition(s) known to interfere with absorption, distribution, metabolism, or excretion of the study product (e.g., Crohn's disease, short bowel, acute or chronic pancreatitis, or pancreatic insufficiency).