General PopulationiTARGETNCT06166810
Capture of Healthy Gut Bacteria Associated to High Fiber Diet
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 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… Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- General Population
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 24 Oct 2023to 3 Nov 2026
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: General population residing in Clermont-Ferrand (France)
Who may be able to join
- 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.
Who cannot join
- 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);
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- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: In Silico and in Vitro Targeting of Healthy Gut Bacteria With Fiber Degrading Metabolic Potential
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.
- Conditions
- General Population
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 3 years
Secondary outcomes (4)
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
Measured: Up to 3 years
growth capacity of the isolates
To characterize the growth (growth monitoring by optical density) of the isolates of interest.
Measured: Up to 3 years
Functional potential of the isolates
To characterize the genomic features of the isolates of interest (functional potential through genome annotation).
Measured: up to 3 years.
Phenotypic caracterization of the isolates
To characterize phenotypically the isolates of interest by API gallery.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study start24 Oct 2023
- Primary completion31 Dec 2025
- Study completion3 Nov 2026
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
- Prospective
- Enrolment
- 10 participants (actual)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de Recherche en Nutrition Humaine d'Auvergne
- Responsible party
- Sponsor
- Investigators
- Victoria MESLIER, PhD, Study director, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'EnvironnementClaire CHERBUY, PhD, Study director, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06166810
- Sponsor's protocol ID
- 2023-A01677-38
- Acronym
- iTARGET
- Status last verified
- Nov 2026
- First submitted
- 4 Dec 2023
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No sharing planned
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Silico and in Vitro Targeting of Healthy Gut Bacteria With Fiber Degrading Metabolic Potential
- ClinicalTrials.gov ID
- NCT06166810
- Acronym / sponsor ID
- iTARGET / 2023-A01677-38
- Conditions
- General Population
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'EnvironnementUniversity, hospital or other
- Collaborators
- Centre de Recherche en Nutrition Humaine d'Auvergne
- Study start
- 24 Oct 2023 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 3 Nov 2026 (actual)
- First posted
- 12 Dec 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 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- General population residing in Clermont-Ferrand (France)
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (14 listed)
- 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;
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
Isolation and culture of one isolate from each target species
Time frame: Up to 3 years
Successful isolation and culture of at least one isolate from each target species previously identified through metagenomic data analyses.
4 secondary outcomes
metagenomic profiles in relation to dietary profiles
Time frame: Up to 3 years
growth capacity of the isolates
Time frame: Up to 3 years
Functional potential of the isolates
Time frame: up to 3 years.
Phenotypic caracterization of the isolates
Time frame: Up to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Derived from this study: PubMed 40224142Caille 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.
- Individual participant dataSharing planned: No. No sharing planned
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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. This study is not recruiting at the moment.
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
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 6 inclusion and 14 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: finished, as of the sponsor's last update on 6 Nov 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Isolation and culture of one isolate from each target species (time frame: Up to 3 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 NCT06166810, 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 6 Nov 2026.