CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 30 enrolled / 30 target
Drug / intervention
Fecal sampling +2 morebiological
Likely dose
50 mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT07276464
NCT07276464N/ACompletedOn Track (4.0/mo)Completion was 1mo ago

Characterization of the Gut Microbiota Metagenomic Signature According to Physical Fitness and Its Implications for Intestinal Health.

University of Rennes 2·observational·Posted Dec 11, 2025·Updated Jun 23, 2026

In Brief

An observational study evaluating Maximal incremental exercise test, Submaximal exercise test, and 1 other intervention for Healthy. Completed, enrolled 30 participants across 1 site.

Detailed Summary

The gut microbiota comprises all microorganisms inhabiting the digestive tract, evolving throughout life under the influence of various intrinsic and extrinsic factors. Under healthy conditions, the microbiota remains stable, resilient, and maintains a symbiotic relationship with its host. Conversely, dysbiosis refers to an alteration in microbial composition and function, which has been linked to diseases such as inflammatory bowel disease (IBD). IBD, including Crohn's disease and ulcerative colitis, is associated with a disrupted microbiota compared to healthy individuals, leading to impaired intestinal barrier integrity and activation of local inflammatory pathways. Increasing evidence also suggests that the gut microbiota of athletes differs from that of physically inactive individuals, showing greater microbial diversity and higher concentrations of short-chain fatty acids (SCFAs). In this context, the present clinical study aims to characterize the bacterial metagenome of the gut microbiota across a continuum ranging from inactive individuals to elite athletes with high or very high energy demands. The ultimate goal of this project is to determine whether specific gut microbiota composition and functional profiles are associated with different levels of exercise capacity, and to create a fecal microbiota biobank for future research on intestinal health.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesFrance
Collaborators--

Timeline

N/ACompletedFinished
2026
First PostedDec 11, 2025
Enrollment StartNov 17, 2025
Primary CompletionMay 9, 2026
Study CompletionJun 18, 2026
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 7 months ago

Arms & Interventions

Low to moderate active subjectsother

V̇O₂max : 40-50 ml/min/kg

Diagnostic Test: Maximal incremental exercise testDiagnostic Test: Submaximal exercise testBiological: Fecal sampling
Trained subjectsother

V̇O₂max : 50-65 ml/min/kg

Diagnostic Test: Maximal incremental exercise testDiagnostic Test: Submaximal exercise testBiological: Fecal sampling
Highly trained subjectsother

V̇O₂max \> 65 ml/min/kg

Diagnostic Test: Maximal incremental exercise testDiagnostic Test: Submaximal exercise testBiological: Fecal sampling

Interventions

Maximal incremental exercise testother

Participants will perform this test on a cycle ergometer. Gas exchange will be continuously measured throughout the test, and blood lactate will be sampled at regular intervals until maximal oxygen consumption is reached.

Submaximal exercise testother

A 25-min submaximal exercise test on ergocycle under fasting condition. Gas exchanges are measured during all the test and blood lactate will be sampled at regular intervals.

Fecal samplingbiological

Fecal samples will be collected in order to (1) conduct metagenomic and metabolomic analyses to characterize the gut microbiota composition and function, and (2) create a fecal biobank for future research involving fecal microbiota transplantation in mice.