To Assess the Effect of Collagen on Gastrointestinal Discomfort in Healthy Adults With Gastrointestinal Symptoms.
NCT06937801, Not applicable, Completed, Rousselot BVBA
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | To Assess the Effect of Collagen on Gastrointestinal Discomfort in Healthy Adults With Gastrointestinal Symptoms. | ClinicalTrials.gov |
| NCT number | NCT06937801 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 116 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Rousselot BVBA | ClinicalTrials.gov |
| Conditions | Gastrointestinal Disorders | ClinicalTrials.gov |
| Interventions | Collagen Peptide, Placebo | ClinicalTrials.gov |
| First posted | 2025-04-22 | ClinicalTrials.gov |
| Last updated | 2026-05-01 | ClinicalTrials.gov |
Registered outcomes 29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | To assess the impact of the Test Product on perceived GI discomfort in healthy adults compared to a placebo | Baseline to Week 8 | Gastrointestinal Symptom Rating Scale (GSRS) total score (From 1-7). A higher score is a worse outcome. | ClinicalTrials.gov |
| Secondary | To assess the impact of the TP on perceived GI symptoms in healthy adults compared to a placebo | Baseline to Week 8 | GSRS dimension scores of reflux, diarrhea, abdominal pain, indigestion and constipation. Score (From 1-7). A higher score is a worse outcome. | ClinicalTrials.gov |
| Secondary | To assess the impact of the TP on perceived GI discomfort and symptoms in healthy adults compared to a placebo | Baseline to Week 4 | 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. | ClinicalTrials.gov |
| Secondary | 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 | Change in the abundance of Bifidobacteriaceae (B. longum) in the stool sample as assessed by qPCR | ClinicalTrials.gov |
| Secondary | 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 | Change in the abundance of Bifidobacteriaceae (B. bifidum) in the stool sample as assessed by qPCR | ClinicalTrials.gov |
| Secondary | 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 | Change in the abundance of Pevotellaceae (P. copri) in the stool sample as assessed by qPCR | ClinicalTrials.gov |
| Secondary | 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 | Change in the abundance of Pevotellaceae (P. Stercorea) in the stool sample as assessed by qPCR | ClinicalTrials.gov |
| Secondary | 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 | Change in the abundance of Bacteroides (B. Cellulosilyticus) in the stool sample as assessed by qPCR | ClinicalTrials.gov |
| Secondary | 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 | Change in the abundance of Bacteroides (B. thetaiotaomicron) in the stool sample as assessed by qPCR | ClinicalTrials.gov |
| Secondary | 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 | Change in the abundance of Bacteroides (B. intestinalis) in the stool sample as assessed by qPCR | ClinicalTrials.gov |
| Secondary | 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 | Change in the abundance of Bacteroides (B. caecimuris) in the stool sample as assessed by qPCR | ClinicalTrials.gov |
| Secondary | 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 | Change in the abundance of Bacteroides (B. fragilis) in the stool sample as assessed by qPCR | ClinicalTrials.gov |
| Secondary | 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 | Change in the abundance of Lactobacillaceae (L. salivarus) in the stool sample as assessed by qPCR | ClinicalTrials.gov |
| Secondary | 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 | Change in the abundance of Lactobacillaceae (L. paracasei) in the stool sample as assessed by qPCR | ClinicalTrials.gov |
| Secondary | 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 | Change in the abundance of Ruminococccaceae (F. prausnitzii) in the stool sample as assessed by qPCR | ClinicalTrials.gov |
| Secondary | 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 | Change in the abundance of Lachnospiraceae (R. hominis) in the stool sample as assessed by qPCR. | ClinicalTrials.gov |
| Secondary | To assess the effect of the TP on mood/anxiety in healthy adults compared to a placebo | Baseline to Week 8 | 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. | ClinicalTrials.gov |
| Secondary | To assess the effect of the TP on perceived stress in healthy adults compared to a placebo | Baseline to Week 8 | Change in Perceived Stress Scale -10 score - The score is from 0-40, a higher score is worse. | ClinicalTrials.gov |
| Secondary | To assess the effect of the TP on quality of life in healthy adults compared to a placebo | Baseline to Week 8 | Change in Research and Development Short Form - 36 score. The score is from 0-100, a higher score is better. | ClinicalTrials.gov |
| Secondary | To assess the effect of the TP on cognitive function in healthy adults compared to a placebo | Baseline to Week 8 | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 4
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Dimensional Change Card Sort | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)