NCT05758961

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…).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100,000

participants targeted

Target at P75+ for all trials

Timeline
200mo left

Started Sep 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress18%
Sep 2022Sep 2042

Study Start

First participant enrolled

September 15, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 8, 2023

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2027

Expected
15 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2042

Last Updated

January 17, 2025

Status Verified

January 1, 2025

Enrollment Period

5 years

First QC Date

February 1, 2023

Last Update Submit

January 16, 2025

Conditions

General Population

Outcome Measures

Primary Outcomes (1)

  • 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.

    5 up to 15 years

Secondary Outcomes (5)

  • Study the variations in the gut microbiota as a function of microbial profile

    5 up to 15 years

  • Study the variations in the gut microbiota as a function of age

    5 up to 15 years

  • Study the variations in the gut microbiota as a function of socio-demographic and anthropometric characteristics

    5 up to 15 years

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

    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.

    5 up to 15 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

General population residing in France

You may qualify if:

  • 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);
  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre de Recherche sur Volontaire

Bobigny, 93000, France

RECRUITING

Related Publications (1)

  • 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.

    PMID: 40358997DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Fecal samples

Study Officials

  • Robert BENAMOUZIG, Pr

    APHP

    PRINCIPAL INVESTIGATOR

  • Joël DORE, Pr

    INRAE

    STUDY CHAIR

Central Study Contacts

Robert BENAMOUZIG, Pr

CONTACT

00148955434robert.benamouzig@aphp.fr

Mourad BENALLAOUA, PhD

CONTACT

0033148955024mourad.benallaoua@aphp.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2023

First Posted

March 8, 2023

Study Start

September 15, 2022

Primary Completion (Estimated)

September 15, 2027

Study Completion (Estimated)

September 15, 2042

Last Updated

January 17, 2025

Record last verified: 2025-01

Locations

FR(1)