NCT06941090: NUTRIGUT

Nutrition, Gut Microbiota and Health : Feces Sample Collection in NutriNet-Santé Participants

Recruiting now NA Last updated 23 April 2025

What this trial tests

NA trial testing sampling stool in Gut Microbiome in 10,000 participants. Currently enrolling.

Timeline

15 December 2023

Primary endpoint
15 December 2033

15 December 2033

Quick facts

Lead sponsor	Institut National de la Santé Et de la Recherche Médicale, France
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	10,000
Start date	15 December 2023
Primary completion	15 December 2033
Estimated completion	15 December 2033
Sites	1 location across France

Drugs / interventions tested

• sampling stool

Conditions studied

• Gut Microbiome — all drugs for Gut Microbiome →

Sponsor

Institut National de la Santé Et de la Recherche Médicale, France — full company profile →

Who can join

18 and older, any sex, with Gut Microbiome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The gut microbiota is currently attracting increasing attention from the scientific community and also from the general public, as evidence of its role in human physiology has been highlighted. Microbial signatures have also been associated with various pathologies (e.g. obesity, diabetes, gastrointestinal disorders, neurodegenerative diseases), but the causality of these associations is still uncertain. Among the factors that may influence the composition of the gut microbiota (e.g. lifestyle, hygiene, medication, genetics, environment), nutrition would a major role. The major changes in lifestyle and diet observed over recent decades are strongly suspected of disrpting the host-gut microbiota balance.

In addition to their nutrient content, our diets also contain other bioactive compounds (e.g. polyphenols) and raise new issues (e.g. temporal structure of diets, food processing, presence of additives or contaminants such as pesticide residues, intake of dietary supplements, dietary exclusions, glycemic index) that is necessary to take into account. Thus, it is mandatory to explore and characterize in a more precise way, within large samples consisting of individuals with varied characteristics, the way in which the composition of the gut microbiota is influenced by the host's diet and its health consequences.

The aim of this research is therefore to study the links between nutrition, gut microbiota profiles and health. To do this, the research will implement large-scale stool sample collection from participants in the NutriNet-Santé cohort ("Nutrinautes"), thus constituting a "microbiota" sub-cohort.

A target of N=10,000 participants in the NutriNet-Santé cohort will be recruited on a voluntary basis. A selection will then be made among Nutrinautes willing to participate in the research (which may be more numerous than necessary) to maximize the diversity of profiles. Participants will be informed of their selection or non-selection by e-mail. A second stool sample will also be collected 2-3 months after the first for a sub-sample of N=300 to assess intra-individual variability in microbiota profiles. The selected participants will receive a stool self-sampling kit with detailed instructions by post to their home address. The pseudonymized samples will be returned by mail by the participant to the processing laboratory, which will determine their gut microbiota characteristics by 16S rDNA sequencing and/or " shotgun " sequencing. The gut microbiota profiles will then be analyzed in a pseudonymised manner in association with diet and health, using data collected as part of the NutriNet-Santé cohort follow-up (e.g. food consumption, prevalence and incidence of pathologies, biological data, anthropometric characteristics, medication intake, socio-demographic characteristics, lifestyle).

Publications & conference data

No peer-reviewed publications indexed yet for this trial.