Characterization of the Gut Microbiota Signature According to Physical Fitness and Its Implicatio… (NCT07276464) | Clinical Trial Compass
CompletedNot Applicable
Characterization of the Gut Microbiota Signature According to Physical Fitness and Its Implications for Intestinal Health.
France30 participantsStarted 2025-11-17
Plain-language 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.
Who can participate
Age range
18 Years – 30 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male participant
* Aged between 18 and 30 years (inclusive)
* Body Mass Index (BMI) between 18 and 25 kg/m² (inclusive)
* No history of gastrointestinal disease, including inflammatory bowel disease
* Be a non-smoker.
* Have a regular bowel transit (1-2 bowel movements per day or every other day) without recurrent episodes of diarrhea or constipation
* Having provided free, informed, and written consent to participate in the study
* Training status :
* Low to moderate active subjects : Perform 2 to 4 hours per week of moderate to vigorous physical activity (VO₂max between 40 and 50 mL·min-¹·kg-¹).
* Trained subjects : Perform 5 to 7 hours per week of regular endurance training for at least one year (VO₂max between 50 and 65 mL·min-¹·kg-¹).
Highly trained subjects : Perform at least 10 hours per week of structured endurance training, with daily or twice-daily sessions (VO₂max greater than 65 mL·min-¹·kg-¹).
Exclusion Criteria:
* History of cardiovascular disease.
* Presence of a metabolic disorder (e.g., diabetes).
* Use of antibiotics, antifungal, or antiparasitic agents within the past 3 months, or planned use during participation in the study.
* Use of prebiotic and/or probiotic supplements within the 7 days preceding the study, providing ≥10⁸ CFU or organisms per day.
* Current use of medication for chronic pain management, including paracetamol, vasodilators, homeopathic treatments, or aspirin at doses \>500 mg/day.
* Simultaneous participat…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.