NCT06955572已完成不适用
Descriptive Study of the Gene Count in Faecal Microbiota During the Course of Various Pathologies and Correlation With the Clinical Phenotype
University Hospital, Rouen1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2023年2月28日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Gene richness of faecal microbiota
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Gene richness of faecal microbiota
时间窗: At enrollment visit, Month 2
Measuring the gene richness of faecal microbiota in Healthy volunteers arm
次要结局
- Diversity of bacterial species(At enrollment visit, Month 2)
- Metagenomic data library(At enrollment visit, Month 2)
- Discriminating gene count threshold(At enrollment visit, Month 2)
研究者
研究点 (1)
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