The French Gut: Characterization of Gut Microbiota Profiles in France

General Population Clinical Trial

Official title:

The French Gut : the French Microbiota

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05758961
• Other study ID #: 2021-A01439-32
• Status: Recruiting
• Start date: September 15, 2022
• Est. completion date: September 15, 2042

Study information

• Verified date: December 2022
• Source: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
• Contact: Robert BENAMOUZIG, Pr
• Phone: 00148955434
• Email: robert.benamouzig[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

" 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…).

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,…)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100000
• Est. completion date: September 15, 2042
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Men or women 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).

Related Conditions & MeSH terms

• General Population

Locations

Country	Name	City	State
France	Centre de Recherche sur Volontaire	Bobigny

Sponsors (2)

Lead Sponsor	Collaborator
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement	Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characterization of the intestinal microbiota of participants in the "French Gut" project	The main evaluation criterion is the percentage of return of faecal samples with study of the quality of the DNA collected. This pilot phase will also make it possible to test the study tools on a full-scale basis and, if necessary, to improve them.	5 up to 15 years
Secondary	Microbial profile	Microbial profile of the sample describing the presence and abundance in the samples of each of the 10.4 million intestinal microbial genes listed in the IGC2 catalog (Integrated Gene Catalog 2);	5 up to 15 years
Secondary	Presence and abundance of different taxonomic ranks	Presence and abundance of different taxonomic ranks, from phylum to species and strain;	5 up to 15 years
Secondary	Micribiota diversity and richness	Richness and diversity of the microbiota (genes and species);	5 up to 15 years
Secondary	Functional modules and metabolic pathways	Functional modules, corresponding to metabolic pathways coded by the species detected in each sample;	5 up to 15 years
Secondary	Presence and abundance of the microbiota genes	Presence and abundance of each of the 10.4 million intestinal microbial genes listed in the IGC2 catalog as well as all the taxonomic levels resulting from them according to: Age; Socio-demographic and anthropometric characteristics; Lifestyle and eating habits; The presence of known pathologies on inclusion or during the follow-up of certain pathologies identified by the analysis of data from health questionnaires and SNDS data.	5 up to 15 years