Microbiota
Conditions
Keywords
faecal microbiota
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.
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.
Interventions
DIAGNOSTIC_TESTPatients with colorectal cancer
Analysis of the lower fecal gene count (fGC) compared with the control group
DIAGNOSTIC_TESTPatients with Parkinson's disease
Analysis of the lower fecal gene count (fGC) compared with the control group
DIAGNOSTIC_TESTPatients with non-alcoholic steatohepatitis
Analysis of the lower fecal gene count (fGC) compared with the control group
DIAGNOSTIC_TESTPatients with obesity
Analysis of the lower fecal gene count (fGC) compared with the control group
DIAGNOSTIC_TESTHealthy volunteers
Determination of the number of bacterial faecal genes (fGC, fecal Gene Count) inferior reference
Sponsors
University Hospital, Rouen
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gene richness of faecal microbiota | At enrollment visit, Month 2 | Measuring the gene richness of faecal microbiota in Patients with colorectal cancer arm |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diversity of bacterial species | At enrollment visit, Month 2 | Gene counting from metagenomic sequencing in Patients with colorectal cancer arm |
| Metagenomic data library | At enrollment visit, Month 2 | Creation of a metagenomic data library referencing the data collected |
| Discriminating gene count threshold | At enrollment visit, Month 2 | Identify a gene count threshold that discriminates against the degree of severity of the disease (colorectal cancer) |
Countries
France
Outcome results
None listed