The French Gut: Characterization of Gut Microbiota Profiles in France

Study Overview
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Brief Summary
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 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…).

Detailed Description
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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,…)

Official Title
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The French Gut : the French Microbiota

Conditions
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General Population

Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Micribiota diversity and richness | Richness and diversity of the microbiota (genes and species); | 5 up to 15 years | 
| Functional modules and metabolic pathways | Functional modules, corresponding to metabolic pathways coded by the species detected in each sample; | 5 up to 15 years | 
| 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 |