Le French Gut: Characterization of Gut Microbiota Profiles in France

Le French Gut : the French Microbiota

" The French Gut " is a national contribution aiming to collect 100,000 faecal samples and associated nutritional and clinical data by 2027. Le French Gut is initiated by MetaGenoPolis-INRAE, supported by INRAE with Prof. R. Benamouzig, (AP-HP) as principal investigator of the project. The main goal of this national trial is a better understanding of the observed heterogeneity between gut microbiome of healthy subjects, its connections with the diet and lifestyle, but also changes in gut microbiota associated with diseases (diabetes, obesity, allergies, cancer, Parkinson, Alzheimer…).

Study Overview

• Status: Recruiting
• Conditions: General Population

Detailed Description

At the 14th International Conference on Genomics (ICG-14), scientists from China, Sweden, Denmark, France and Latvia launched The Million Microbiome of Humans Project (MMHP) and agreed to collaborate on a large-scale microbial metagenomic project. The overarching goal is to build the world's largest database of human microbiota with one million microbial samples from the intestines, mouth, skin and reproductive system. Therefore, making it possible to characterize the microbiota of people according to age, gender, height, weight, etc.

As a founding member of the MMHP, INRAE will bring the French national contribution: 100 000 faecal samples and associated nutritional and clinical data from France, by 2027, through Le French Gut project. Initiated by the MGP research unit, Le French Gut is led by INRAE and the AP-HP (Public Assistance-Hospitals of Paris), with the support and collaboration of a consortium of members from medical, scientific and industrial sectors.

In order to be a participant of the project, volunteers will need to fill out an online questionnaire with 60 questions about their lifestyle, their dietary habits and their medical background. The second requirement is the stool sampling, at home.

Main scientific targets of this project are the following:

• Build a map of the intestinal microbiota in France, reflecting differences in term of gut microbiome through ages, gender, regions of life, diets, habits and medical status;
• Describe and better understand the heterogeneity between gut microbiota of healthy subjects and investigate the connection between this heterogeneity with diet and habits.
• Describe the variations of the intestinal microbiota associated with the presence and development of certain diseases (chronic diseases, neurodevelopmental disorders, neurodegenerative diseases,…)

• Study Type: Observational
• Enrollment (Estimated): 100000

Contacts and Locations

• Study Contact: Name: ROBERT BENAMOUZIG, Pr; Phone Number: 00148955434; Email: robert.benamouzig@aphp.fr
• Study Contact Backup: Name: MOURAD BENALLAOUA, PhD; Phone Number: 0033148955024; Email: mourad.benallaoua@aphp.fr

Study Locations

• France
  • Bobigny, France, 93000
    • Recruiting
    • Centre de Recherche sur Volontaire
    • Contact: Robert BENAMOUZIG, Pr; Phone Number: +33148955434; Email: robert.benamouzig@aphp.fr
    • Contact: Mourad BENALLAOUA, PhD; Phone Number: +33148955024; Email: mourad.benallaoua@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

General population residing in France

Description

Inclusion Criteria:

• Persons over the age of 18 living in France.
• Consent form signed electronically.

Non inclusion Criteria:

• Non-adult person (declarative);
• Person not living in France (declarative);
• Persons subject to a protective measure, in particular under guardianship or curatorship or unable to express their consent (declarative);
• Person having had a colectomy (declarative);
• Person with a digestive stoma (declarative);
• Person who has not signed the consent;
• Person who did not answer the entry questionnaire;
• Person who has not sent a compliant stool sample;
• Antibiotic intake in the 3 months before inclusion (declarative);
• Performing a colonoscopy in the 3 months preceding inclusion (declarative).

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Characterize the heterogeneity and diversity of the gut microbiota of subjects living in France	The gut microbiota of participants will be characterized by describing the presence and abundance in the samples of each gut microbial genes listed in our up-to-date gene catalogue. From these data, the presence and abundance of the different taxonomic ranks will be deduced, ranging from a fine granularity at species and strain level to a more 'zoomed out' phylum level. The richness and diversity of the microbiome (genes and species) will be described. The functional modules, corresponding to the metabolic pathways encoded by the species detected in each sample, will be determined.	5 up to 15 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study the variations in the gut microbiota as a function of microbial profile		5 up to 15 years
Study the variations in the gut microbiota as a function of age		5 up to 15 years
Study the variations in the gut microbiota as a function of socio-demographic and anthropometric characteristics	Richness and diversity of the microbiota (genes and species);	5 up to 15 years
Study the variations in the gut microbiota as a function of lifestyle and eating habits		5 up to 15 years
Study the variations in the gut microbiota as a function of presence of known pathologies at inclusion, occurrence during follow-up of certain pathologies identified by analysis of data from health from health questionnaires and SNDS data.		5 up to 15 years

Collaborators and Investigators

• Sponsor: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
• Collaborators: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: ROBERT BENAMOUZIG, Pr, APHP; Study Chair: Joël DORE, Pr, INRAE

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2022
• Primary Completion (Estimated): September 15, 2027
• Study Completion (Estimated): September 15, 2042

Study Registration Dates

• First Submitted: February 1, 2023
• First Submitted That Met QC Criteria: February 24, 2023
• First Posted (Actual): March 8, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 16, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2021-A01439-32

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No