Clinical trial NCT06937801: To Assess the Effect of Collagen on Gastrointestinal Discomfort in Healthy Adults With Gastrointestinal Symptoms.
Official title: A Randomized, Double-blind, Placebo-controlled Clinical Trial to Assess the Effect of Collagen Peptide on Perceived Gastrointestinal Discomfort in Healthy Adult Participants With Presence of Gastrointestinal Symptoms
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastrointestinal Disorders
Keywords: Gastrointestinal discomfort
gastrointestinal symptoms
Lead sponsor: Rousselot BVBA
Sponsor class: INDUSTRY
Collaborators: name: Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
First posted: 2025-04-22
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, Double-Blind, placebo-controlled
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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 taken orally.
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 supplement intake, and lifestyle for the last 3 months before screening and agree to maintain them 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 the questionnaires, carry out all study-related procedures and agree to the requirements of this study.

Exclusion Criteria:

1. Individuals who are lactating, pregnant or planning to become pregnant during the study.
2. Have a known sensitivity, intolerability, or allergy to any of the study products or their excipients.
3. Current COVID-19 infections, or currently have the post COVID-19 condition as defined by World Health Organization (WHO).
4. Recent history of an episode of acute GI illness such as nausea, vomiting, or diarrhea.
5. 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).
6. 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.
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 renal failure), 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 situ cervical cancer), unless recovery occurred more than 5 years before the screening visit.
11. 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.).
12. Reports a clinically significant illness during the 28 days before the first dose of study product.
13. Major surgery in 3 months prior to screening or planned major surgery during the study.
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-patient intervention program) or use that in the opinion of the investigator may be of a concern for the study.
15. 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.
16. Living in the same household as another currently/previously enrolled participant in the present study.
17. Any other medical condition/situation or use of medications/supplements/therapies that, in the opinion of the investigator, may adversely affect the participant's ability to participate in the study or its measures or pose a significant risk to the participant.

Primary outcomes:
measure: To assess the impact of the Test Product on perceived GI discomfort in healthy adults compared to a placebo
timeFrame: Baseline to Week 8
Secondary outcomes:
measure: To assess the impact of the TP on perceived GI symptoms in healthy adults compared to a placebo
timeFrame: Baseline to Week 8
measure: To assess the impact of the TP on perceived GI discomfort and symptoms in healthy adults compared to a placebo
timeFrame: Baseline to Week 4
measure: 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
timeFrame: Baseline to Week 8
measure: 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
timeFrame: Baseline to Week 8
measure: 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
timeFrame: Baseline to Week 8
measure: 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
timeFrame: Baseline to Week 8
measure: 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
timeFrame: Baseline to Week 8
measure: 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
timeFrame: Baseline to Week 8
measure: 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
timeFrame: Baseline to Week 8
measure: 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
timeFrame: Baseline to Week 8
measure: 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
timeFrame: Baseline to Week 8
measure: 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
timeFrame: Baseline to Week 8
measure: 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
timeFrame: Baseline to Week 8
measure: 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
timeFrame: Baseline to Week 8
measure: 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
timeFrame: Baseline To Week 8
measure: To assess the effect of the TP on mood/anxiety in healthy adults compared to a placebo
timeFrame: Baseline to Week 8
measure: To assess the effect of the TP on perceived stress in healthy adults compared to a placebo
timeFrame: Baseline to Week 8
measure: To assess the effect of the TP on quality of life in healthy adults compared to a placebo
timeFrame: Baseline to Week 8
measure: To assess the effect of the TP on cognitive function in healthy adults compared to a placebo
timeFrame: Baseline to Week 8
measure: To assess the effect of the TP on cognitive function in healthy adults compared to a placebo
timeFrame: Week 8
measure: To assess the effect of the TP on cognitive function in healthy adults compared to a placebo
timeFrame: Baseline to Week 8
measure: To assess the effect of the TP on cognitive function in healthy adults compared to a placebo
timeFrame: Baseline to Week 8
measure: To assess the effect of the TP on intestinal permeability in healthy adults compared to a placebo
timeFrame: Baseline to Week 8
Other outcomes:
measure: To assess the safety of the TP
timeFrame: Baseline to Week 8
measure: To assess the safety of the TP
timeFrame: Baseline to Week 8
measure: To assess the safety of the TP
timeFrame: Baseline to Week 8
measure: To assess the safety of the TP
timeFrame: Baseline to Week 8
measure: To assess the safety of the TP
timeFrame: Baseline to Week 8
Locations:
city: Guelph
country: Canada
facility: Nutrasource Site (Apex Trials)
state: Ontario
Study officials:
affiliation: Rousselot BV
name: Nicoletta Virgilio
role: STUDY_DIRECTOR
References: