Descriptive Study of the Gene Count in Faecal Microbiota (METARICH)

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.

Study Overview

• Status: Completed
• Conditions: Microbiota
• Intervention / Treatment: Diagnostic test: Patients with colorectal cancer; Diagnostic test: Patients with Parkinson's disease; Diagnostic test: Patients with non-alcoholic steatohepatitis; Diagnostic test: Patients with obesity; Diagnostic test: Healthy volunteers

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 Type: Observational
• Enrollment (Actual): 400

Contacts and Locations

Study Locations

• France
  • Rouen, France, 76031
    • University Rouen Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

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.

Description

Inclusion Criteria:

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

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.

Exclusion Criteria:

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
• 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gene richness of faecal microbiota	Measuring the gene richness of faecal microbiota in Patients with colorectal cancer arm	At enrollment visit, Month 2
Gene richness of faecal microbiota	Measuring the gene richness of faecal microbiota in Patients with obesity arm	At enrollment visit, Month 2
Gene richness of faecal microbiota	Measuring the gene richness of faecal microbiota in Patients with Parkinson's disease arm	At enrollment visit, Month 2
Gene richness of faecal microbiota	Measuring the gene richness of faecal microbiota in Patients with non-alcoholic steatohepatitis arm	At enrollment visit, Month 2
Gene richness of faecal microbiota	Measuring the gene richness of faecal microbiota in Healthy volunteers arm	At enrollment visit, Month 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diversity of bacterial species	Gene counting from metagenomic sequencing in Patients with colorectal cancer arm	At enrollment visit, Month 2
Diversity of bacterial species	Gene counting from metagenomic sequencing in Patients with obesity arm	At enrollment visit, Month 2
Diversity of bacterial species	Gene counting from metagenomic sequencing in Patients with Parkinson's disease arm	At enrollment visit, Month 2
Diversity of bacterial species	Gene counting from metagenomic sequencing in Patients with non-alcoholic steatohepatitis arm	At enrollment visit, Month 2
Diversity of bacterial species	Gene counting from metagenomic sequencing in Healthy volunteers arm	At enrollment visit, Month 2
Metagenomic data library	Creation of a metagenomic data library referencing the data collected	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)	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)	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)	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)	At enrollment visit, Month 2

Collaborators and Investigators

• Sponsor: University Hospital, Rouen

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2023
• Primary Completion (Actual): May 22, 2024
• Study Completion (Actual): July 22, 2024

Study Registration Dates

• First Submitted: April 24, 2025
• First Submitted That Met QC Criteria: April 24, 2025
• First Posted (Actual): May 2, 2025

Study Record Updates

• Last Update Posted (Actual): May 2, 2025
• Last Update Submitted That Met QC Criteria: April 24, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: faecal microbiota
• Other Study ID Numbers: 2021/196/OB; ID RCB : 2022-A01921-42 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data provided will be the property of the sponsor and will be used solely for its own research activities.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No