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Completed

NCT Number: NCT06955572

Descriptive Study of the Gene Count in Faecal Microbiota

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.

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Rouen Hospital

Rouen, 76031, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. 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

  2. Gene richness of faecal microbiota

    Time frame: At enrollment visit, Month 2

    Measuring the gene richness of faecal microbiota in Patients with obesity arm

  3. 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

  4. 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

  5. Gene richness of faecal microbiota

    Time frame: At enrollment visit, Month 2

    Measuring the gene richness of faecal microbiota in Healthy volunteers arm

Secondary outcomes

  1. Diversity of bacterial species

    Time frame: At enrollment visit, Month 2

    Gene counting from metagenomic sequencing in Patients with colorectal cancer arm

  2. Diversity of bacterial species

    Time frame: At enrollment visit, Month 2

    Gene counting from metagenomic sequencing in Patients with obesity arm

  3. Diversity of bacterial species

    Time frame: At enrollment visit, Month 2

    Gene counting from metagenomic sequencing in Patients with Parkinson's disease arm

  4. Diversity of bacterial species

    Time frame: At enrollment visit, Month 2

    Gene counting from metagenomic sequencing in Patients with non-alcoholic steatohepatitis arm

  5. Diversity of bacterial species

    Time frame: At enrollment visit, Month 2

    Gene counting from metagenomic sequencing in Healthy volunteers arm

  6. Metagenomic data library

    Time frame: At enrollment visit, Month 2

    Creation of a metagenomic data library referencing the data collected

  7. Discriminating gene count threshold

    Time frame: At enrollment visit, Month 2

    Identify a gene count threshold that discriminates against the degree of severity of the disease (colorectal cancer)

  8. Discriminating gene count threshold

    Time frame: At enrollment visit, Month 2

    Identify a gene count threshold that discriminates against the degree of severity of the disease (obesity)

  9. Discriminating gene count threshold

    Time frame: At enrollment visit, Month 2

    Identify a gene count threshold that discriminates against the degree of severity of the disease (Parkinson)

  10. Discriminating gene count threshold

    Time frame: At enrollment visit, Month 2

    Identify a gene count threshold that discriminates against the degree of severity of the disease (non-alcoholic steatohepatitis)

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Official study title

Descriptive Study of the Gene Count in Faecal Microbiota During the Course of Various Pathologies and Correlation With the Clinical Phenotype

Acronym: METARICH

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 2, 2025
Registry last updated
May 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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