Gut MicrobiomeNUTRIGUTNCT06941090
Nutrition, Gut Microbiota and Health : Feces Sample Collection in NutriNet-Santé Participants
A study testing sampling stool in people with Gut Microbiome, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
The gut microbiota is currently attracting increasing attention from the scientific community and also from the general public, as evidence of its role in human physiology has been highlighted. Microbial signatures have also been associated with various pathologies (e.g. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gut Microbiome
- What is being tested?
- sampling stool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,000 participants
- Where
- 1 siteFrance
- Study dates
- 15 Dec 2023to 15 Dec 2033
- Phase
- Interventional
- 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
Who may be able to join
- Participant in the NutriNet-Santé cohort
- Age ≥ 18 years
- Resident of metropolitan France
- Written comprehension frenc
Who cannot join
- Person subject to a safeguard of justice measure
- Person belonging to one of the categories of vulnerable persons
- Diagnosis of COVID-19 (clinically or by PCR) in the month prior to collection
- Contact with a COVID-19 patient in the month prior to collection
- Suspicion of COVID-19 in the month preceding collection (clinical signs of infection : fever associated with headache, respiratory signs, os anosmia/ageusia)
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
EREN SMBH Université Sorbonne Paris Nord
Bobigny
Mathilde, Touvier, 01.48.38.89.33, m.touvier@eren.smbh.univ-paris13.fr
About this study
The gut microbiota is currently attracting increasing attention from the scientific community and also from the general public, as evidence of its role in human physiology has been highlighted. Microbial signatures have also been associated with various pathologies (e.g. obesity, diabetes, gastrointestinal disorders, neurodegenerative diseases), but the causality of these associations is still uncertain. Among the factors that may influence the composition of the gut microbiota (e.g. lifestyle, hygiene, medication, genetics, environment), nutrition would a major role. The major changes in lifestyle and diet observed over recent decades are strongly suspected of disrpting the host-gut microbiota balance.
In addition to their nutrient content, our diets also contain other bioactive compounds (e.g. polyphenols) and raise new issues (e.g. temporal structure of diets, food processing, presence of additives or contaminants such as pesticide residues, intake of dietary supplements, dietary exclusions, glycemic index) that is necessary to take into account. Thus, it is mandatory to explore and characterize in a more precise way, within large samples consisting of individuals with varied characteristics, the way in which the composition of the gut microbiota is influenced by the host's diet and its health consequences.
Read more
The aim of this research is therefore to study the links between nutrition, gut microbiota profiles and health. To do this, the research will implement large-scale stool sample collection from participants in the NutriNet-Santé cohort ("Nutrinautes"), thus constituting a "microbiota" sub-cohort.
A target of N=10,000 participants in the NutriNet-Santé cohort will be recruited on a voluntary basis. A selection will then be made among Nutrinautes willing to participate in the research (which may be more numerous than necessary) to maximize the diversity of profiles. Participants will be informed of their selection or non-selection by e-mail. A second stool sample will also be collected 2-3 months after the first for a sub-sample of N=300 to assess intra-individual variability in microbiota profiles. The selected participants will receive a stool self-sampling kit with detailed instructions by post to their home address. The pseudonymized samples will be returned by mail by the participant to the processing laboratory, which will determine their gut microbiota characteristics by 16S rDNA sequencing and/or " shotgun " sequencing. The gut microbiota profiles will then be analyzed in a pseudonymised manner in association with diet and health, using data collected as part of the NutriNet-Santé cohort follow-up (e.g. food consumption, prevalence and incidence of pathologies, biological data, anthropometric characteristics, medication intake, socio-demographic characteristics, lifestyle).
- Conditions
- Gut Microbiome
- Being tested
- sampling stool
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sampling stoolOther
Participants will receive a self-sampling stool kit with detailed instructions by mail to their home address. Samples will be mailed back by the participant to the treatment laboratory, which will determine the characteristics of their intestinal microbiota.
| Study group | Role | What they receive |
|---|---|---|
| stool sampling | Experimental | The research consists in collecting stool samples from a sub-sample of participants already included in the NutriNet-Santé cohort. The stool collection will enable us to study the characteristics of the intestinal microbiota in relation to nutrition on the one hand, and health on the other, based on data collected during participation in the NutriNet-Santé cohort. Receives: Other: sampling stool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterization of gut microbiota profile by 16S r RNA gene sequencing
Performed on self sampling of stools at home. It is used to characterize the taxonomic profiles of intestinal microbiota. It will be applied on all samples
Measured: At inclusion, 2 to 3 months later
Characterization of gut microbiota profile by " shotgun " metagenomic sequencing
Performed on self sampling of stools at home. It provides more detailled characterization of the taxonomic and functional profiles of the intestinal microbiota. It will be applied to a smaller number of samples (no more than 300).
Measured: At inclusion, 2 to 3 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start15 Dec 2023
- Primary completion15 Dec 2033 (estimated)
- Study completion15 Dec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gut MicrobiomeStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06941090
- Sponsor's protocol ID
- C21-60
- Acronym
- NUTRIGUT
- Status last verified
- Jul 2026
- First submitted
- 16 Apr 2025
- Last updated
- 31 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutrition, Gut Microbiota and Health : Feces Sample Collection in NutriNet-Santé Participants
- ClinicalTrials.gov ID
- NCT06941090
- Acronym / sponsor ID
- NUTRIGUT / C21-60
- Conditions
- Gut Microbiome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- 15 Dec 2033 (estimated)
- Study completion
- 15 Dec 2033 (estimated)
- First posted
- 23 Apr 2025 (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 gut microbiota is currently attracting increasing attention from the scientific community and also from the general public, as evidence of its role in human physiology has been highlighted. Microbial signatures have also been associated with various pathologies (e.g. obesity, diabetes, gastrointestinal disorders, neurodegenerative diseases), but the causality of these associations is still uncertain. Among the factors that may influence the composition of the gut microbiota (e.g. lifestyle, hygiene, medication, genetics, environment), nutrition would a major role. The major changes in lifestyle and diet observed over recent decades are strongly suspected of disrpting the host-gut microbiota balance.
In addition to their nutrient content, our diets also contain other bioactive compounds (e.g. polyphenols) and raise new issues (e.g. temporal structure of diets, food processing, presence of additives or contaminants such as pesticide residues, intake of dietary supplements, dietary exclusions, glycemic index) that is necessary to take into account. Thus, it is mandatory to explore and characterize in a more precise way, within large samples consisting of individuals with varied characteristics, the way in which the composition of the gut microbiota is influenced by the host's diet and its health consequences.
The aim of this research is therefore to study the links between nutrition, gut microbiota profiles and health. To do this, the research will implement large-scale stool sample collection from participants in the NutriNet-Santé cohort ("Nutrinautes"), thus constituting a "microbiota" sub-cohort.
A target of N=10,000 participants in the NutriNet-Santé cohort will be recruited on a voluntary basis. A selection will then be made among Nutrinautes willing to participate in the research (which may be more numerous than necessary) to maximize the diversity of profiles. Participants will be informed of their selection or non-selection by e-mail. A second stool sample will also be collected 2-3 months after the first for a sub-sample of N=300 to assess intra-individual variability in microbiota profiles. The selected participants will receive a stool self-sampling kit with detailed instructions by post to their home address. The pseudonymized samples will be returned by mail by the participant to the processing laboratory, which will determine their gut microbiota characteristics by 16S rDNA sequencing and/or " shotgun " sequencing. The gut microbiota profiles will then be analyzed in a pseudonymised manner in association with diet and health, using data collected as part of the NutriNet-Santé cohort follow-up (e.g. food consumption, prevalence and incidence of pathologies, biological data, anthropometric characteristics, medication intake, socio-demographic characteristics, lifestyle).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| stool sampling | Experimental | Other: sampling stoolThe research consists in collecting stool samples from a sub-sample of participants already included in the NutriNet-Santé cohort. The stool collection will enable us to study the characteristics of the intestinal microbiota in relation to nutrition on the one hand, and health on the other, based on data collected during participation in the NutriNet-Santé cohort. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participant in the NutriNet-Santé cohort
- Age ≥ 18 years
- Resident of metropolitan France
- Written comprehension frenc
Key exclusion criteria (5 listed)
- Person subject to a safeguard of justice measure
- Person belonging to one of the categories of vulnerable persons
- Diagnosis of COVID-19 (clinically or by PCR) in the month prior to collection
- Contact with a COVID-19 patient in the month prior to collection
- Suspicion of COVID-19 in the month preceding collection (clinical signs of infection : fever associated with headache, respiratory signs, os anosmia/ageusia)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sampling stoolParticipants will receive a self-sampling stool kit with detailed instructions by mail to their home address. Samples will be mailed back by the participant to the treatment laboratory, which will determine the characteristics of their intestinal microbiota. | Other | stool sampling |
Primary outcome
Characterization of gut microbiota profile by 16S r RNA gene sequencing
Time frame: At inclusion, 2 to 3 months later
Performed on self sampling of stools at home. It is used to characterize the taxonomic profiles of intestinal microbiota. It will be applied on all samples
Characterization of gut microbiota profile by " shotgun " metagenomic sequencing
Time frame: At inclusion, 2 to 3 months later
Performed on self sampling of stools at home. It provides more detailled characterization of the taxonomic and functional profiles of the intestinal microbiota. It will be applied to a smaller number of samples (no more than 300).
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 31 Jul 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sampling stool in people with Gut Microbiome, run by Institut National de la Santé Et de la Recherche Médicale, France 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 4 inclusion and 5 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 31 Jul 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 Mathilde Touvier (01.48.38.89.33, m.touvier@eren.smbh.univ-paris13.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterization of gut microbiota profile by 16S r RNA gene sequencing (time frame: At inclusion, 2 to 3 months later). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jul 2026.