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Le French Gut: Characterization of Gut Microbiota Profiles in France

Recruiting
Conditions
General Population
Registration Number
NCT05758961
Lead Sponsor
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
Brief 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...).

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,...)

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
100000
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).
Exclusion Criteria

Not provided

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Characterize the heterogeneity and diversity of the gut microbiota of subjects living in France5 up to 15 years

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.

Secondary Outcome Measures
NameTimeMethod
Study the variations in the gut microbiota as a function of microbial profile5 up to 15 years
Study the variations in the gut microbiota as a function of age5 up to 15 years
Study the variations in the gut microbiota as a function of socio-demographic and anthropometric characteristics5 up to 15 years

Richness and diversity of the microbiota (genes and species);

Study the variations in the gut microbiota as a function of lifestyle and eating habits5 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

Trial Locations

Locations (1)

Centre de Recherche sur Volontaire

🇫🇷

Bobigny, France

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