Capture of Healthy Gut Bacteria Associated to High Fiber Diet (NCT06166810) | Clinical Trial Compass
RecruitingNot Applicable
Capture of Healthy Gut Bacteria Associated to High Fiber Diet
France10 participantsStarted 2023-10-24
Plain-language summary
The role of the intestinal microbiota on health is now well recognised, and diet is one of the factors influencing the maintenance of a healthy intestinal microbiota. More specifically, the consumption of fruit, vegetables and cereals is associated with good health and, in particular, with an increase in the relative abundance of bacterial groups described as beneficial. To date, a large number of bacterial species in the intestinal microbiota have yet to be isolated and cultivated, which limits the characterisation of their potential health benefits. In order to isolate and cultivate these intestinal bacteria, it is particularly relevant to recruit individuals with a high-fibre diet.
Who can participate
Age range
20 Years – 50 Years
Sex
ALL
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:
* Healthy adult subjects ;
* Age between 20 and 50 (limits included) ;
* BMI between 18.5 and 25 kg/m2 (excluding limits) ;
* Consumption of more than 5 portions of fruit and vegetables a day;
* Intake of at least 25g of dietary fibre per day;
* A varied diet with little processed food.
Exclusion Criteria:
* Antibiotics and/or transit modulators taken in the 3 months prior to sampling;
* Known pathologies;
* Current treatment;
* History of digestive surgery having an impact on the microbiota, deemed incompatible with the study (bariatric surgery);
* Consumption of food supplements based on protein preparations, probiotics or prebiotics;
* Smoking (even occasionally);
* Alcohol consumption \> 2 glasses (i.e. 20 g) per day;
* Intense sporting activity;
* Pregnant or breast-feeding women;
* Persons under legal protection (curatorship, guardianship, etc.);
* Volunteers taking part in another intervention study;
* Persons refusing to be registered on the French Ministry of Health's Fichier National des Volontaires Sains (National Register of Healthy Volunteers);
* Subject not affiliated to the social security system;
* Subject in a period of exclusion from a previous study or having received a total amount of compensation exceeding 6000 euros over the 12 consecutive months prior to the start of the trial (after verification in the Fichier des Volontaires pour la Recherche Biomédicale).
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.
What they're measuring
1
Isolation and culture of one isolate from each target species
Timeframe: Up to 3 years
Trial details
NCT IDNCT06166810
SponsorInstitut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement