Descriptive Study of the Gene Count in Faecal Microbiota

NCT06955572 | Completed

• 2 other identifiers: 2021/196/OBID RCB : 2022-A01921-42
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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. The pathologies chosen for the study were selected because they are associated in the literature with changes in the faecal microbiota.

Conditions

Microbiota

Keywords

faecal microbiota

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (10)

• Diversity of bacterial species

  At enrollment visit, Month 2

• Diversity of bacterial species

  At enrollment visit, Month 2

• Diversity of bacterial species

  At enrollment visit, Month 2

• Diversity of bacterial species

  At enrollment visit, Month 2

• Diversity of bacterial species

  At enrollment visit, Month 2

Interventions

Patients with colorectal cancer DIAGNOSTIC_TEST

Analysis of the lower fecal gene count (fGC) compared with the control group

Patients with Parkinson's disease DIAGNOSTIC_TEST

Analysis of the lower fecal gene count (fGC) compared with the control group

Patients with non-alcoholic steatohepatitis DIAGNOSTIC_TEST

Analysis of the lower fecal gene count (fGC) compared with the control group

Patients with obesity DIAGNOSTIC_TEST

Analysis of the lower fecal gene count (fGC) compared with the control group

Healthy volunteers DIAGNOSTIC_TEST

Determination of the number of bacterial faecal genes (fGC, fecal Gene Count) inferior reference

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

University Rouen Hospital

Rouen, 76031, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

human faeces

MeSH Terms

Interventions

Adiposity

Intervention Hierarchy (Ancestors)

Body Fat Distribution; Body Weights and Measures; Body Constitution; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Body Composition; Biochemical Phenomena; Chemical Phenomena; Metabolism; Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2025
• First Posted: May 2, 2025
• Study Start: February 28, 2023
• Primary Completion: May 22, 2024
• Study Completion: July 22, 2024
• Last Updated: May 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)