NCT06166810

Brief Summary

The role of the intestinal microbiota on health is now well recognised, and diet is one of the factors influencing the maintenance of a healthy intestinal microbiota. More specifically, the consumption of fruit, vegetables and cereals is associated with good health and, in particular, with an increase in the relative abundance of bacterial groups described as beneficial. To date, a large number of bacterial species in the intestinal microbiota have yet to be isolated and cultivated, which limits the characterisation of their potential health benefits. In order to isolate and cultivate these intestinal bacteria, it is particularly relevant to recruit individuals with a high-fibre diet.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2023

Typical duration 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 Start

First participant enrolled

October 24, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 4, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 12, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2026

Completed
Last Updated

January 15, 2026

Status Verified

September 1, 2025

Enrollment Period

2.2 years

First QC Date

December 4, 2023

Last Update Submit

January 14, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Isolation and culture of one isolate from each target species

    Successful isolation and culture of at least one isolate from each target species previously identified through metagenomic data analyses.

    Up to 3 years

Secondary Outcomes (4)

  • metagenomic profiles in relation to dietary profiles

    Up to 3 years

  • growth capacity of the isolates

    Up to 3 years

  • Functional potential of the isolates

    up to 3 years.

  • Phenotypic caracterization of the isolates

    Up to 3 years

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

General population residing in Clermont-Ferrand (France)

You may qualify if:

  • Healthy adult subjects ;
  • Age between 20 and 50 (limits included) ;
  • BMI between 18.5 and 25 kg/m2 (excluding limits) ;
  • Consumption of more than 5 portions of fruit and vegetables a day;
  • Intake of at least 25g of dietary fibre per day;
  • A varied diet with little processed food.

You may not qualify if:

  • Antibiotics and/or transit modulators taken in the 3 months prior to sampling;
  • Known pathologies;
  • Current treatment;
  • History of digestive surgery having an impact on the microbiota, deemed incompatible with the study (bariatric surgery);
  • Consumption of food supplements based on protein preparations, probiotics or prebiotics;
  • Smoking (even occasionally);
  • Alcohol consumption \> 2 glasses (i.e. 20 g) per day;
  • Intense sporting activity;
  • Pregnant or breast-feeding women;
  • Persons under legal protection (curatorship, guardianship, etc.);
  • Volunteers taking part in another intervention study;
  • Persons refusing to be registered on the French Ministry of Health's Fichier National des Volontaires Sains (National Register of Healthy Volunteers);
  • Subject not affiliated to the social security system;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CRNH Auvergne

Clermont-Ferrand, 63009, France

RECRUITING

Related Publications (1)

  • Caille A, Connan C, Lyon Belgy N, Borezee E, Cherbuy C, Meunier N, Meslier V. Positive nutritional selection of adults with healthy lifestyle and high daily fiber consumption for the isolation of beneficial intestinal bacteria: The iTARGET cohort study protocol. MethodsX. 2025 Mar 17;14:103268. doi: 10.1016/j.mex.2025.103268. eCollection 2025 Jun.

Biospecimen

Retention: SAMPLES WITH DNA

Fecal samples

Study Officials

  • Victoria MESLIER, PhD

    Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

    STUDY DIRECTOR
  • Claire CHERBUY, PhD

    Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
24 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2023

First Posted

December 12, 2023

Study Start

October 24, 2023

Primary Completion

December 31, 2025

Study Completion

January 31, 2026

Last Updated

January 15, 2026

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

No sharing planned

Locations