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

NCT06937801 | Completed

• 1 other identifier: R02-24-01-T0070
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gastrointestinal Disorders

Keywords

Gastrointestinal discomfort; gastrointestinal symptoms

Outcome Measures

Primary Outcomes (1)

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

  Gastrointestinal Symptom Rating Scale (GSRS) total score (From 1-7). A higher score is a worse outcome.

  Baseline to Week 8

Secondary Outcomes (23)

• To assess the impact of the TP on perceived GI symptoms in healthy adults compared to a placebo

  Baseline to Week 8

• To assess the impact of the TP on perceived GI discomfort and symptoms in healthy adults compared to a placebo

  Baseline to Week 4

• To assess the effect of the TP on the modulation of the gut microbiota composition, in particular growth stimulation of beneficial bacteria, in healthy adults compared to a placebo

  Baseline to Week 8

• To assess the effect of the TP on the modulation of the gut microbiota composition, in particular growth stimulation of beneficial bacteria, in healthy adults compared to a placebo

  Baseline to Week 8

• To assess the effect of the TP on the modulation of the gut microbiota composition, in particular growth stimulation of beneficial bacteria, in healthy adults compared to a placebo

  Baseline to Week 8

Other Outcomes (5)

• To assess the safety of the TP

  Baseline to Week 8

• To assess the safety of the TP

  Baseline to Week 8

• To assess the safety of the TP

  Baseline to Week 8

Study Arms (2)

Placebo

PLACEBO COMPARATOR

single dose

Other: Placebo

Collagen Peptide

ACTIVE COMPARATOR

Dissolve in water, single dose, 10 g

Dietary Supplement: Collagen Peptide

Interventions

Collagen Peptide DIETARY_SUPPLEMENT

10g Collagen Hydrolysate per sachet

Collagen Peptide

Placebo OTHER

Placebo - active ingredients: N/A

Placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Agree to follow the restrictions on lifestyle.
• Agree to use acceptable contraceptive methods.
• Willing and able to give voluntary consent, able to understand and read the questionnaires, carry out all study-related procedures and agree to the requirements of this study.

You may not qualify if:

• 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).
• Have a history of heart/cardiovascular disease, renal disease (dialysis or renal failure), hepatic impairment/disease, immune disorders and/or immunocompromised (i.e., HIV/AIDS).
• Have a history of cancer (except localized skin cancer without metastases or in situ cervical cancer), unless recovery occurred more than 5 years before the screening visit.
• Are receiving treatments for or have been hospitalized in the last 12 months for psychiatric disorders (e.g., depression, generalized anxiety disorder, bipolar disorder, schizophrenia, etc.).
• Reports a clinically significant illness during the 28 days before the first dose of study product.
• Major surgery in 3 months prior to screening or planned major surgery during the study.
• 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-patient intervention program) or use that in the opinion of the investigator may be of a concern for the study.
• Current enrollment or past participation in another study with any product(s) with at least one active ingredient within 28 days before first dose of study product or longer.

Sponsors & Collaborators

• Rousselot BVBA: lead
• Nutrasource Pharmaceutical and Nutraceutical Services, Inc.: collaborator

Study Sites (1)

Nutrasource Site (Apex Trials)

Guelph, Ontario, N1G 0B4, Canada

Location

MeSH Terms

Conditions

Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• Nicoletta Virgilio

  Rousselot BV

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Double-Blind, placebo-controlled

Study Record Dates

• First Submitted: April 4, 2025
• First Posted: April 22, 2025
• Study Start: May 8, 2025
• Primary Completion: November 21, 2025
• Study Completion: November 21, 2025
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)