Clinical trial NCT05758961: Le French Gut: Characterization of Gut Microbiota Profiles in France
Official title: Le French Gut : the French Microbiota
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: General Population
Lead sponsor: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
Sponsor class: OTHER
Collaborators: name: Assistance Publique - Hôpitaux de Paris
First posted: 2023-03-08
Enrollment: 100000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: General population residing in France

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,...)

Eligibility criteria: 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).

Primary outcomes:
measure: Characterize the heterogeneity and diversity of the gut microbiota of subjects living in France
timeFrame: 5 up to 15 years
Secondary outcomes:
measure: Study the variations in the gut microbiota as a function of microbial profile
timeFrame: 5 up to 15 years
measure: Study the variations in the gut microbiota as a function of age
timeFrame: 5 up to 15 years
measure: Study the variations in the gut microbiota as a function of socio-demographic and anthropometric characteristics
timeFrame: 5 up to 15 years
measure: Study the variations in the gut microbiota as a function of lifestyle and eating habits
timeFrame: 5 up to 15 years
measure: 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.
timeFrame: 5 up to 15 years
Other outcomes:
Locations:
city: Bobigny
country: France
facility: Centre de Recherche sur Volontaire
Study officials:
affiliation: APHP
name: Robert BENAMOUZIG, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: INRAE
name: Joël DORE, Pr
role: STUDY_CHAIR
References: