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

Last updated: May 13, 2025
Sponsor: Rousselot BVBA
Overall Status: Active - Recruiting

Phase

N/A

Condition

Gastrointestinal Diseases And Disorders

Hemorrhoids

Ulcers

Treatment

Collagen Peptide

Placebo

Clinical Study ID

NCT06937801
R02-24-01-T0070
  • Ages 18-64
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Healthy adults from 18 to 64 years of age (inclusive).

  2. Have a BMI between 18.0 to 34.9 kg/m2 (inclusive).

  3. In good general health as determined by the investigator.

  4. Are able to consume an animal-sourced powder product when mixed with water and takenorally.

  5. Have a presence of GI symptoms as confirmed by a GSRS average score between 2 and 5 (inclusive).

  6. Have maintained consistent dietary habits, including medication and supplementintake, and lifestyle for the last 3 months before screening and agree to maintainthem throughout the study.

  7. Agree to avoid anal penetration for 72 h prior to each fecal sample collection.

  8. Agree to follow the restrictions on concomitant treatments, and lifestyle.

  9. Agree to use acceptable contraceptive methods.

  10. Willing and able to give voluntary consent, able to understand and read thequestionnaires, carry out all study-related procedures and agree to the requirementsof this study.

Exclusion

Exclusion Criteria:

  1. Individuals who are lactating, pregnant or planning to become pregnant during thestudy.

  2. Have a known sensitivity, intolerability, or allergy to any of the study products ortheir excipients.

  3. Current COVID-19 infections, or currently have the post COVID-19 condition asdefined by World Health Organization (WHO).

  4. Recent history of an episode of acute GI illness such as nausea, vomiting, ordiarrhea.

  5. Have Type I diabetes, uncontrolled Type II diabetes, uncontrolled high bloodpressure (≥140 systolic or ≥90 diastolic mmHg), or uncontrolled thyroid disease ("uncontrolled" defined as being unmedicated, have an unstable use of medicationwithin 3 months prior to screening, or have a stable use of medication for 3 monthsbut still have uncontrolled conditions).

  6. Have a current diagnosis or history of irritable bowel syndrome (IBS), inflammatorybowel disease (IBD), functional constipation or diarrhea (defined by the ROME IVdiagnostic criteria), celiac disease, malabsorption, gastroparesis, endometriosis oreating disorder.

  7. Have a chronic inflammatory condition/disease (e.g., rheumatoid arthritis,ulcerative colitis, lupus).

  8. 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).

  9. Have a history of heart/cardiovascular disease, renal disease (dialysis or renalfailure), hepatic impairment/disease, immune disorders and/or immunocompromised (i.e., HIV/AIDS).

  10. Have a history of cancer (except localized skin cancer without metastases or in situcervical cancer), unless recovery occurred more than 5 years before the screeningvisit.

  11. Are receiving treatments for or have been hospitalized in the last 12 months forpsychiatric disorders (e.g., depression, generalized anxiety disorder, bipolardisorder, schizophrenia, etc.).

  12. Reports a clinically significant illness during the 28 days before the first dose ofstudy product.

  13. Major surgery in 3 months prior to screening or planned major surgery during thestudy.

  14. Have a history of alcohol or substance abuse in the 12 months prior to screening (including having been hospitalized for such in an in-patient or out-patientintervention program) or use that in the opinion of the investigator may be of aconcern for the study.

  15. Current enrollment or past participation in another study with any product(s) withat least one active ingredient within 28 days before first dose of study product orlonger.

  16. Living in the same household as another currently/previously enrolled participant inthe present study.

  17. Any other medical condition/situation or use of medications/supplements/therapiesthat, in the opinion of the investigator, may adversely affect the participant'sability to participate in the study or its measures or pose a significant risk tothe participant.

Study Design

Total Participants: 116
Treatment Group(s): 2
Primary Treatment: Collagen Peptide
Phase:
Study Start date:
May 04, 2025
Estimated Completion Date:
January 27, 2026

Study Description

This double-blind, placebo-controlled trial aims to assess the efficacy of collagen peptides in addressing gastrointestinal discomfort, gut microbiota composition, gut permeability, mood, anxiety, perceived stress, quality of life and cognitive function. The study will include healthy adults experiencing gastrointestinal symptoms while excluding individuals with chronic illnesses or recent infections that might impact the results.

Connect with a study center

  • Nutrasource Site (Apex Trials)

    Guelph, Ontario N1G 0B4
    Canada

    Active - Recruiting

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