CClinicalTrials.gg
RecruitingNCT06166810iTARGETUpdated Jun 29, 2026

Capture of Healthy Gut Bacteria Associated to High Fiber Diet

An observational study in General Population, sponsored by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement. Recruiting at 1 site in France. Open to participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-29.

Sponsored by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
10
Ages
20 Years to 50 Years
Sex
All
01

Study 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.

Read the detailed description

Since two decades, numerous studies have been performed to better understand the role of the gut microbiota in health and disease. An imbalance in the intestinal microbiota, known as dysbiosis, is frequently described as a cause of many chronic diseases and metabolic dysfunctions in humans. Among the factors that play an important role in maintaining this balance, diet plays a predominant role. 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. Modulating the intestinal microbiota via the or directly by providing these beneficial bacteria (next generation probiotics NGPs) is therefore a possible promising approach for the prevention and/or treatment of pathologies. To date, a large number of bacterial species in the intestinal microbiota have yet to be isolated and cultivated, which limits the characterization of their potential health benefits. Having strains that can be isolated and cultured is an essential step in phenotyping and characterization. In order to isolate and cultivate these intestinal bacteria, it is particularly important to recruit individuals with a high-fiber diet. In this context, a positive selection of donors, based on their dietary profiles highly enriched in fiber, is essential. In this study, the aim is to identify in silico unprecedented potentially new beneficial gut bacteria, and isolate, culture and characterize these bacterial species for their potential. This will be an innovative approach, using culturomics tools guided by metagenomics to isolate them. To do this, the fecal samples of 10 healthy volunteers will be collected with a regular and diversified intake of fruit, vegetables and cereals, which encourage the growth of beneficial micro-organisms and increase the richness of the intestinal microbiota.

02

Conditions studied

  • General Population
03

Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

General population residing in Clermont-Ferrand (France)

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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;
  • Subject in a period of exclusion from a previous study or having received a total amount of compensation exceeding 6000 euros over the 12 consecutive months prior to the start of the trial (after verification in the Fichier des Volontaires pour la Recherche Biomédicale).
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
10 participants (estimated)
Target follow-up
24 Months
Patient registry
Yes
Biospecimen retention
Samples with dna
05

What researchers measure

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.

    Time frame: Up to 3 years

Secondary outcomes

  1. metagenomic profiles in relation to dietary profiles

    To obtain metagenomic profiles using shotgun sequencing of the gut microbiota (bacterial species), in relation to dietary profiles

    Time frame: Up to 3 years

  2. growth capacity of the isolates

    To characterize the growth (growth monitoring by optical density) of the isolates of interest.

    Time frame: Up to 3 years

  3. Functional potential of the isolates

    To characterize the genomic features of the isolates of interest (functional potential through genome annotation).

    Time frame: up to 3 years.

  4. Phenotypic caracterization of the isolates

    To characterize phenotypically the isolates of interest by API gallery.

    Time frame: Up to 3 years

06

Study locations

1 of 1 sites recruiting
07

References and documents

Publications

  • 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. PubMed 40224142 ↗

Individual participant data

Plan to share: No — No sharing planned

08

Registry details

Key details

Study ID
NCT06166810
Lead sponsor
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
Collaborators
Centre de Recherche en Nutrition Humaine d'Auvergne
Responsible party
Sponsor
First posted
Dec 12, 2023
Start date
Oct 24, 2023
Primary completion
Dec 31, 2025
Completion
Dec 31, 2026 (estimated)
Last update
Jun 29, 2026

Study contacts

Aurélie CAILLE, MSc
Contact
acaille@chu-clermontferrand.fr
04 73 75 42 73
Nathalie MEUNIER, PhD
Contact
nmeunier@chu-clermontferrand.fr
04 73 75 42 73
Victoria MESLIER, PhD
study director · Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
Claire CHERBUY, PhD
study director · Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion