Gastrointestinal DisordersNCT06937801
To Assess the Effect of Collagen on Gastrointestinal Discomfort in Healthy Adults With Gastrointestinal Symptoms.
A study testing Collagen Peptide in people with Gastrointestinal Disorders, run by Rousselot BVBA at 1 site in Canada.
Trial summary
This study will enroll healthy adults with perceived gastrointestinal symptoms to evaluate the effect of collagen peptides compared to placebo. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Disorders
- What is being tested?
- Collagen Peptide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 1 siteCanada
- Study dates
- 8 May 2025to 21 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- Living in the same household as another currently/previously enrolled participant in the present study.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
This study will enroll healthy adults with perceived gastrointestinal symptoms to evaluate the effect of collagen peptides compared to placebo.
Read the 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.
- Conditions
- Gastrointestinal Disorders
- Being tested
- Collagen Peptide, Placebo
- Keywords
- Gastrointestinal discomfort, gastrointestinal symptoms
- Medical subject headings
- Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collagen PeptideDietary supplement
10g Collagen Hydrolysate per sachet
PlaceboOther
Placebo - active ingredients: N/A
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | single dose Receives: Other: Placebo |
| Collagen Peptide | Active comparator | Dissolve in water, single dose, 10 g Receives: Dietary Supplement: Collagen Peptide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
GSRS dimension scores of reflux, diarrhea, abdominal pain, indigestion and constipation. Score (From 1-7). A higher score is a worse outcome.
Measured: Baseline to Week 8
To assess the impact of the TP on perceived GI discomfort and symptoms in healthy adults compared to a placebo
GSRS total score and dimension scores of reflux, diarrhea, abdominal pain, indigestion and constipation. Score (From 1-7). A higher score is a worse outcome.
Measured: 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
Change in the abundance of Bifidobacteriaceae (B. longum) in the stool sample as assessed by qPCR
Measured: 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
Change in the abundance of Bifidobacteriaceae (B. bifidum) in the stool sample as assessed by qPCR
Measured: 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
Change in the abundance of Pevotellaceae (P. copri) in the stool sample as assessed by qPCR
Measured: 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
Change in the abundance of Pevotellaceae (P. Stercorea) in the stool sample as assessed by qPCR
Measured: 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
Change in the abundance of Bacteroides (B. Cellulosilyticus) in the stool sample as assessed by qPCR
Measured: 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
Change in the abundance of Bacteroides (B. thetaiotaomicron) in the stool sample as assessed by qPCR
Measured: 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
Change in the abundance of Bacteroides (B. intestinalis) in the stool sample as assessed by qPCR
Measured: 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
Change in the abundance of Bacteroides (B. caecimuris) in the stool sample as assessed by qPCR
Measured: 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
Change in the abundance of Bacteroides (B. fragilis) in the stool sample as assessed by qPCR
Measured: 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
Change in the abundance of Lactobacillaceae (L. salivarus) in the stool sample as assessed by qPCR
Measured: 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
Change in the abundance of Lactobacillaceae (L. paracasei) in the stool sample as assessed by qPCR
Measured: 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
Change in the abundance of Ruminococccaceae (F. prausnitzii) in the stool sample as assessed by qPCR
Measured: 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
Change in the abundance of Lachnospiraceae (R. hominis) in the stool sample as assessed by qPCR.
Measured: Baseline To Week 8
To assess the effect of the TP on mood/anxiety in healthy adults compared to a placebo
Change in Brunnel Mood Scale questionnaire scores or anger, confusion, depression, fatigue, tension and vigour. The Scale is from 0-16, a higher score is worse.
Measured: Baseline to Week 8
To assess the effect of the TP on perceived stress in healthy adults compared to a placebo
Change in Perceived Stress Scale -10 score - The score is from 0-40, a higher score is worse.
Measured: Baseline to Week 8
To assess the effect of the TP on quality of life in healthy adults compared to a placebo
Change in Research and Development Short Form - 36 score. The score is from 0-100, a higher score is better.
Measured: Baseline to Week 8
To assess the effect of the TP on cognitive function in healthy adults compared to a placebo
Change from baseline to Week 8 in Trail Making Test score. Time is recorded in seconds to complete the test, a higher time is worse.
Measured: Baseline to Week 8
To assess the effect of the TP on cognitive function in healthy adults compared to a placebo
Change in Dimensional Change Card Sort Test score of executive function. The score is from 0-12, a higher score is better..
Measured: Week 8
To assess the effect of the TP on cognitive function in healthy adults compared to a placebo
Change in Flanker Inhibitory Control and Attention Test score of executive function. The test measures time in milliseconds, a higher time is worse.
Measured: Baseline to Week 8
To assess the effect of the TP on cognitive function in healthy adults compared to a placebo
Change in Stroop Colour and Word Test score of executive function. The test measures time in milliseconds, a higher time is worse.
Measured: Baseline to Week 8
To assess the effect of the TP on intestinal permeability in healthy adults compared to a placebo
Change in serum LPS levels
Measured: Baseline to Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start8 May 2025
- Primary completion21 Nov 2025
- Study completion21 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Double-Blind, placebo-controlled
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rousselot BVBA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
- Responsible party
- Sponsor
- Investigators
- Nicoletta Virgilio, Study director, Rousselot BV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06937801
- Sponsor's protocol ID
- R02-24-01-T0070
- Status last verified
- Apr 2026
- First submitted
- 4 Apr 2025
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06937801
- Acronym / sponsor ID
- R02-24-01-T0070
- Conditions
- Gastrointestinal Disorders
- Keywords
- Gastrointestinal discomfort, gastrointestinal symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Rousselot BVBAIndustry (pharma, biotech, devices)
- Collaborators
- Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
- Study start
- 8 May 2025 (actual)
- Primary completion
- 21 Nov 2025 (actual)
- Study completion
- 21 Nov 2025 (actual)
- First posted
- 22 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized, Double-Blind, placebo-controlled
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Placebosingle dose |
| Collagen Peptide | Active comparator | Dietary Supplement: Collagen PeptideDissolve in water, single dose, 10 g |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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).
Key exclusion criteria (17 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collagen Peptide10g Collagen Hydrolysate per sachet | Dietary supplement | Collagen Peptide |
| PlaceboPlacebo - active ingredients: N/A | Other | Placebo |
Primary outcome
To assess the impact of the Test Product on perceived GI discomfort in healthy adults compared to a placebo
Time frame: Baseline to Week 8
Gastrointestinal Symptom Rating Scale (GSRS) total score (From 1-7). A higher score is a worse outcome.
23 secondary outcomes
To assess the impact of the TP on perceived GI symptoms in healthy adults compared to a placebo
Time frame: Baseline to Week 8
To assess the impact of the TP on perceived GI discomfort and symptoms in healthy adults compared to a placebo
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline To Week 8
To assess the effect of the TP on mood/anxiety in healthy adults compared to a placebo
Time frame: Baseline to Week 8
To assess the effect of the TP on perceived stress in healthy adults compared to a placebo
Time frame: Baseline to Week 8
To assess the effect of the TP on quality of life in healthy adults compared to a placebo
Time frame: Baseline to Week 8
To assess the effect of the TP on cognitive function in healthy adults compared to a placebo
Time frame: Baseline to Week 8
To assess the effect of the TP on cognitive function in healthy adults compared to a placebo
Time frame: Week 8
To assess the effect of the TP on cognitive function in healthy adults compared to a placebo
Time frame: Baseline to Week 8
To assess the effect of the TP on cognitive function in healthy adults compared to a placebo
Time frame: Baseline to Week 8
To assess the effect of the TP on intestinal permeability in healthy adults compared to a placebo
Time frame: Baseline to Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicoletta Virgilio study director
Rousselot BV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collagen Peptide in people with Gastrointestinal Disorders, run by Rousselot BVBA at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the impact of the Test Product on perceived GI discomfort in healthy adults compared to a placebo (time frame: Baseline to Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.