General PopulationNCT05758961
Le French Gut: Characterization of Gut Microbiota Profiles in France
An observational study of General Population, run by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- General Population
- How many people
- 100,000 participants
- Where
- 1 siteFrance
- Study dates
- 15 Sep 2022to 15 Sep 2042
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: General population residing in France
Who may be able to join
- 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);
Show all 13Show fewer
- 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).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre de Recherche sur Volontaire
Bobigny, 93000
Robert BENAMOUZIG, Pr, +33148955434, robert.benamouzig@aphp.fr
Mourad BENALLAOUA, PhD, +33148955024, mourad.benallaoua@aphp.fr
About this study
Official title: 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…).
Read the 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,…)
- Conditions
- General Population
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 up to 15 years
Secondary outcomes (5)
Study the variations in the gut microbiota as a function of microbial profile
Measured: 5 up to 15 years
Study the variations in the gut microbiota as a function of age
Measured: 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);
Measured: 5 up to 15 years
Study the variations in the gut microbiota as a function of lifestyle and eating habits
Measured: 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.
Measured: 5 up to 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start15 Sep 2022
- Primary completion14 Sep 2029 (estimated)
- Study completion15 Sep 2042 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for General PopulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 100,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
- Sponsor type
- University, hospital or other
- Collaborators
- Assistance Publique - Hôpitaux de Paris
- Responsible party
- Sponsor
- Investigators
- Robert BENAMOUZIG, Pr, Principal investigator, APHPJoël DORE, Pr, Study chair, INRAE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05758961
- Sponsor's protocol ID
- 2021-A01439-32
- Status last verified
- Jun 2026
- First submitted
- 1 Feb 2023
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Connan C, Fromentin S, Benallaoua M, Alvarez AS, Pons N, Quinquis B, Morabito C, Nazare JA, Borezee-Durant E; Le French Gut Consortium; Haimet F, Ehrlich SD, Valeille K, Cavezza A, Blottiere H, Veiga P, Almeida M, Dore J, Benamouzig R. Associations Among Diet, Health, Lifestyle, and Gut Microbiota Composition in the General French Population: Protocol for the Le French Gut - Le Microbiote Francais Study. JMIR Res Protoc. 2025 May 13;14:e64894. doi: 10.2196/64894.
PubMed 40358997
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Le French Gut : the French Microbiota
- ClinicalTrials.gov ID
- NCT05758961
- Acronym / sponsor ID
- 2021-A01439-32
- Conditions
- General Population
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'EnvironnementUniversity, hospital or other
- Collaborators
- Assistance Publique - Hôpitaux de Paris
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 14 Sep 2029 (estimated)
- Study completion
- 15 Sep 2042 (estimated)
- First posted
- 8 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
" 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,…)
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- General population residing in France
Key inclusion criteria (13 listed)
- Persons over the age of 18 living in France.
- Consent form signed electronically.
- 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);
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Characterize the heterogeneity and diversity of the gut microbiota of subjects living in France
Time frame: 5 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.
5 secondary outcomes
Study the variations in the gut microbiota as a function of microbial profile
Time frame: 5 up to 15 years
Study the variations in the gut microbiota as a function of age
Time frame: 5 up to 15 years
Study the variations in the gut microbiota as a function of socio-demographic and anthropometric characteristics
Time frame: 5 up to 15 years
Study the variations in the gut microbiota as a function of lifestyle and eating habits
Time frame: 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.
Time frame: 5 up to 15 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Derived from this study: PubMed 40358997Connan C, Fromentin S, Benallaoua M, Alvarez AS, Pons N, Quinquis B, Morabito C, Nazare JA, Borezee-Durant E; Le French Gut Consortium; Haimet F, Ehrlich SD, Valeille K, Cavezza A, Blottiere H, Veiga P, Almeida M, Dore J, Benamouzig R. Associations Among Diet, Health, Lifestyle, and Gut Microbiota Composition in the General French Population: Protocol for the Le French Gut - Le Microbiote Francais Study. JMIR Res Protoc. 2025 May 13;14:e64894. doi: 10.2196/64894.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert BENAMOUZIG, Pr principal investigator
APHP
Joël DORE, Pr study chair
INRAE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of General Population, run by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Robert BENAMOUZIG, Pr (00148955434, robert.benamouzig@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterize the heterogeneity and diversity of the gut microbiota of subjects living in France (time frame: 5 up to 15 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05758961, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.