MicrobiotaMETARICHNCT06955572
Descriptive Study of the Gene Count in Faecal Microbiota
An observational study of Microbiota, run by University Hospital, Rouen at 1 site in France.
Trial summary
The hypothesis of METARICH Study is that it is possible to draw up a profile of the faecal microbiota, which could contribute in the future to the characterisation of certain chronic pathologies. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Microbiota
- What is being tested?
- Patients with colorectal cancer, Patients with Parkinson's disease and Patients with non-alcoholic steatohepatitis
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 28 Feb 2023to 22 Jul 2024
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 60 patients with non-alcoholic steatohepatitis, 60 patients with colorectal cancer, 60 patients with Parkinson's disease, 80 patients 60 patients with obesity and 140 healthy volunteers will be selected.
Who may be able to join
- List of patient inclusion criteria:
- Male or female patient consulting the Rouen University Hospital for one of the 4 pathologies below:
- Obesity (with or without bulimic hyperphagia): BMI greater than 30
- Non-alcoholic steatohepatitis (NASH): Confirmation of the diagnosis of NASH by the clinician
- Colorectal cancer: Confirmation of the diagnosis of colorectal cancer by the clinician
- Parkinson's disease: Confirmation of the diagnosis of Parkinson's disease by the clinician
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- List of inclusion criteria for the control group:
- Adult patient aged less than 75 years.
- Ambulatory patient able to collect stools at home
- Patient who has read and understood the information letter and signed the consent form
- Patient affiliated to the social security system
- Aged between 18 and 75
- Affiliated with a social security scheme
- To the best of the volunteer's knowledge, free from the following pathologies: Obesity, hyperphagia, anorexia, bulimia, Crohn's disease, irritable bowel syndrome, haemorrhagic rectocolitis, NASH, steatosis, colorectal cancer, diabetes (type I and II), ankylosing spondylitis, rheumatoid arthritis, heart failure, atopic dermatitis, bronchopulmonary concer, Parkinson's disease and multiple sclerosis
- A person who has read and understood the information leaflet, signed the consent forms and is able to perform the stool collection.
Who cannot join
- List of patient non-inclusion criteria :
- Patient under guardianship or incapable of giving consent
- Patient at the end of life or whose clinical condition is incompatible with stool collection
- Patient undergoing antibiotic therapy or who has received antibiotic therapy for less than 3 months
- Patient already included in a category 1 interventional clinical trial
- Patient already included in METARICH for another pathology
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- Patient who has had a colonic lavage/emptying for less than 3 months
- List of non-inclusion criteria for the control group:
- Person deprived of liberty by administrative or judicial decision or person subject to a legal adult protection measure, patient under court protection, patient under guardianship or curatorship,
- Person under antibiotic therapy or having received antibiotic therapy for less than 3 months
- Person already included in a category 1 interventional clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Descriptive Study of the Gene Count in Faecal Microbiota During the Course of Various Pathologies and Correlation With the Clinical Phenotype
The hypothesis of METARICH Study is that it is possible to draw up a profile of the faecal microbiota, which could contribute in the future to the characterisation of certain chronic pathologies. The pathologies chosen for the study were selected because they are associated in the literature with changes in the faecal microbiota.
Read the detailed description
All the study data will be collected from the patients' clinical records and from the questionnaires set up (patient inclusion questionnaire and information questionnaire).
- The patient inclusion questionnaires collect the following variables: characteristics of the pathology (precise phenotyping by the clinician, assessment of severity, age, progression) as well as biological parameters obtained in the patient's usual check-ups and current treatments specific to the pathology.
- The patient information questionnaire collects information on lifestyle habits (smoking, alcohol, sporting activities, diet), stool sample data (Bristol scale, day and time of collection), treatment(s) received in the last 3 months and other chronic pathologies.
- Conditions
- Microbiota
- Being tested
- Patients with colorectal cancer, Patients with Parkinson's disease, Patients with non-alcoholic steatohepatitis, Patients with obesity, Healthy volunteers
- Keywords
- faecal microbiota
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients with colorectal cancerDiagnostic test
Analysis of the lower fecal gene count (fGC) compared with the control group
Patients with Parkinson's diseaseDiagnostic test
Analysis of the lower fecal gene count (fGC) compared with the control group
Patients with non-alcoholic steatohepatitisDiagnostic test
Analysis of the lower fecal gene count (fGC) compared with the control group
Patients with obesityDiagnostic test
Analysis of the lower fecal gene count (fGC) compared with the control group
Healthy volunteersDiagnostic test
Determination of the number of bacterial faecal genes (fGC, fecal Gene Count) inferior reference
What is being measured
The primary outcome is the main question the study is designed to answer.
Gene richness of faecal microbiota
Measuring the gene richness of faecal microbiota in Patients with colorectal cancer arm
Measured: At enrollment visit, Month 2
Gene richness of faecal microbiota
Measuring the gene richness of faecal microbiota in Patients with obesity arm
Measured: At enrollment visit, Month 2
Gene richness of faecal microbiota
Measuring the gene richness of faecal microbiota in Patients with Parkinson's disease arm
Measured: At enrollment visit, Month 2
Gene richness of faecal microbiota
Measuring the gene richness of faecal microbiota in Patients with non-alcoholic steatohepatitis arm
Measured: At enrollment visit, Month 2
Gene richness of faecal microbiota
Measuring the gene richness of faecal microbiota in Healthy volunteers arm
Measured: At enrollment visit, Month 2
Secondary outcomes (10)
Diversity of bacterial species
Gene counting from metagenomic sequencing in Patients with colorectal cancer arm
Measured: At enrollment visit, Month 2
Diversity of bacterial species
Gene counting from metagenomic sequencing in Patients with obesity arm
Measured: At enrollment visit, Month 2
Diversity of bacterial species
Gene counting from metagenomic sequencing in Patients with Parkinson's disease arm
Measured: At enrollment visit, Month 2
Diversity of bacterial species
Gene counting from metagenomic sequencing in Patients with non-alcoholic steatohepatitis arm
Measured: At enrollment visit, Month 2
Diversity of bacterial species
Gene counting from metagenomic sequencing in Healthy volunteers arm
Measured: At enrollment visit, Month 2
Metagenomic data library
Creation of a metagenomic data library referencing the data collected
Measured: At enrollment visit, Month 2
Discriminating gene count threshold
Identify a gene count threshold that discriminates against the degree of severity of the disease (colorectal cancer)
Measured: At enrollment visit, Month 2
Discriminating gene count threshold
Identify a gene count threshold that discriminates against the degree of severity of the disease (obesity)
Measured: At enrollment visit, Month 2
Discriminating gene count threshold
Identify a gene count threshold that discriminates against the degree of severity of the disease (Parkinson)
Measured: At enrollment visit, Month 2
Discriminating gene count threshold
Identify a gene count threshold that discriminates against the degree of severity of the disease (non-alcoholic steatohepatitis)
Measured: At enrollment visit, Month 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2025
- Study start28 Feb 2023
- Primary completion22 May 2024
- Study completion22 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MicrobiotaStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06955572
- Sponsor's protocol ID
- 2021/196/OB
- Other IDs
- ID RCB : 2022-A01921-42
- Acronym
- METARICH
- Status last verified
- Apr 2025
- First submitted
- 24 Apr 2025
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data provided will be the property of the sponsor and will be used solely for its own research activities.
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Descriptive Study of the Gene Count in Faecal Microbiota During the Course of Various Pathologies and Correlation With the Clinical Phenotype
- ClinicalTrials.gov ID
- NCT06955572
- Acronym / sponsor ID
- METARICH / 2021/196/OB
- Conditions
- Microbiota
- Keywords
- faecal microbiota
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 28 Feb 2023 (actual)
- Primary completion
- 22 May 2024 (actual)
- Study completion
- 22 Jul 2024 (actual)
- First posted
- 2 May 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 hypothesis of METARICH Study is that it is possible to draw up a profile of the faecal microbiota, which could contribute in the future to the characterisation of certain chronic pathologies. The pathologies chosen for the study were selected because they are associated in the literature with changes in the faecal microbiota.
Detailed description
All the study data will be collected from the patients' clinical records and from the questionnaires set up (patient inclusion questionnaire and information questionnaire).
- The patient inclusion questionnaires collect the following variables: characteristics of the pathology (precise phenotyping by the clinician, assessment of severity, age, progression) as well as biological parameters obtained in the patient's usual check-ups and current treatments specific to the pathology.
- The patient information questionnaire collects information on lifestyle habits (smoking, alcohol, sporting activities, diet), stool sample data (Bristol scale, day and time of collection), treatment(s) received in the last 3 months and other chronic pathologies.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 60 patients with non-alcoholic steatohepatitis, 60 patients with colorectal cancer, 60 patients with Parkinson's disease, 80 patients 60 patients with obesity and 140 healthy volunteers will be selected.
Key inclusion criteria (15 listed)
- Male or female patient consulting the Rouen University Hospital for one of the 4 pathologies below:
- Obesity (with or without bulimic hyperphagia): BMI greater than 30
- Non-alcoholic steatohepatitis (NASH): Confirmation of the diagnosis of NASH by the clinician
- Colorectal cancer: Confirmation of the diagnosis of colorectal cancer by the clinician
- Parkinson's disease: Confirmation of the diagnosis of Parkinson's disease by the clinician
Key exclusion criteria (11 listed)
- Patient under guardianship or incapable of giving consent
- Patient at the end of life or whose clinical condition is incompatible with stool collection
- Patient undergoing antibiotic therapy or who has received antibiotic therapy for less than 3 months
- Patient already included in a category 1 interventional clinical trial
- Patient already included in METARICH for another pathology
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 |
|---|---|---|
| Patients with colorectal cancerAnalysis of the lower fecal gene count (fGC) compared with the control group | Diagnostic test | – |
| Patients with Parkinson's diseaseAnalysis of the lower fecal gene count (fGC) compared with the control group | Diagnostic test | – |
| Patients with non-alcoholic steatohepatitisAnalysis of the lower fecal gene count (fGC) compared with the control group | Diagnostic test | – |
| Patients with obesityAnalysis of the lower fecal gene count (fGC) compared with the control group | Diagnostic test | – |
| Healthy volunteersDetermination of the number of bacterial faecal genes (fGC, fecal Gene Count) inferior reference | Diagnostic test | – |
Primary outcome
Gene richness of faecal microbiota
Time frame: At enrollment visit, Month 2
Measuring the gene richness of faecal microbiota in Patients with colorectal cancer arm
Gene richness of faecal microbiota
Time frame: At enrollment visit, Month 2
Measuring the gene richness of faecal microbiota in Patients with obesity arm
Gene richness of faecal microbiota
Time frame: At enrollment visit, Month 2
Measuring the gene richness of faecal microbiota in Patients with Parkinson's disease arm
Gene richness of faecal microbiota
Time frame: At enrollment visit, Month 2
Measuring the gene richness of faecal microbiota in Patients with non-alcoholic steatohepatitis arm
Gene richness of faecal microbiota
Time frame: At enrollment visit, Month 2
Measuring the gene richness of faecal microbiota in Healthy volunteers arm
10 secondary outcomes
Diversity of bacterial species
Time frame: At enrollment visit, Month 2
Diversity of bacterial species
Time frame: At enrollment visit, Month 2
Diversity of bacterial species
Time frame: At enrollment visit, Month 2
Diversity of bacterial species
Time frame: At enrollment visit, Month 2
Diversity of bacterial species
Time frame: At enrollment visit, Month 2
Metagenomic data library
Time frame: At enrollment visit, Month 2
Discriminating gene count threshold
Time frame: At enrollment visit, Month 2
Discriminating gene count threshold
Time frame: At enrollment visit, Month 2
Discriminating gene count threshold
Time frame: At enrollment visit, Month 2
Discriminating gene count threshold
Time frame: At enrollment visit, Month 2
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 2 May 2025.
- Individual participant dataSharing planned: No. The data provided will be the property of the sponsor and will be used solely for its own research activities.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Microbiota, run by University Hospital, Rouen 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 15 inclusion and 11 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 2 May 2025. 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?
Gene richness of faecal microbiota (time frame: At enrollment visit, Month 2). The study lists 5 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 2 May 2025.