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临床试验/NCT05758961
NCT05758961招募中不适用

Le French Gut : the French Microbiota

Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement1 个研究点 分布在 1 个国家目标入组 100,000 人开始时间: 2022年9月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100,000
试验地点
1
主要终点
Characterize the heterogeneity and diversity of the gut microbiota of subjects living in France

研究概览

简要总结

" The French Gut " is a national contribution aiming to collect 100,000 faecal samples and associated nutritional and clinical data by 2027. Le French Gut is initiated by MetaGenoPolis-INRAE, supported by INRAE with Prof. R. Benamouzig, (AP-HP) as principal investigator of the project. The main goal of this national trial is a better understanding of the observed heterogeneity between gut microbiome of healthy subjects, its connections with the diet and lifestyle, but also changes in gut microbiota associated with diseases (diabetes, obesity, allergies, cancer, Parkinson, Alzheimer...).

详细描述

At the 14th International Conference on Genomics (ICG-14), scientists from China, Sweden, Denmark, France and Latvia launched The Million Microbiome of Humans Project (MMHP) and agreed to collaborate on a large-scale microbial metagenomic project. The overarching goal is to build the world's largest database of human microbiota with one million microbial samples from the intestines, mouth, skin and reproductive system. Therefore, making it possible to characterize the microbiota of people according to age, gender, height, weight, etc.

As a founding member of the MMHP, INRAE will bring the French national contribution: 100 000 faecal samples and associated nutritional and clinical data from France, by 2027, through Le French Gut project. Initiated by the MGP research unit, Le French Gut is led by INRAE and the AP-HP (Public Assistance-Hospitals of Paris), with the support and collaboration of a consortium of members from medical, scientific and industrial sectors.

In order to be a participant of the project, volunteers will need to fill out an online questionnaire with 60 questions about their lifestyle, their dietary habits and their medical background. The second requirement is the stool sampling, at home.

Main scientific targets of this project are the following:

  • Build a map of the intestinal microbiota in France, reflecting differences in term of gut microbiome through ages, gender, regions of life, diets, habits and medical status;
  • Describe and better understand the heterogeneity between gut microbiota of healthy subjects and investigate the connection between this heterogeneity with diet and habits.
  • Describe the variations of the intestinal microbiota associated with the presence and development of certain diseases (chronic diseases, neurodevelopmental disorders, neurodegenerative diseases,...)

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Persons over the age of 18 living in France.
  • Consent form signed electronically.
  • Non inclusion Criteria:
  • Non-adult person (declarative);
  • Person not living in France (declarative);
  • Persons subject to a protective measure, in particular under guardianship or curatorship or unable to express their consent (declarative);
  • Person having had a colectomy (declarative);
  • Person with a digestive stoma (declarative);
  • Person who has not signed the consent;
  • Person who did not answer the entry questionnaire;
  • Person who has not sent a compliant stool sample;
  • Antibiotic intake in the 3 months before inclusion (declarative);
  • Performing a colonoscopy in the 3 months preceding inclusion (declarative).

排除标准

  • 未提供

结局指标

主要结局

Characterize the heterogeneity and diversity of the gut microbiota of subjects living in France

时间窗: 5 up to 15 years

The gut microbiota of participants will be characterized by describing the presence and abundance in the samples of each gut microbial genes listed in our up-to-date gene catalogue. From these data, the presence and abundance of the different taxonomic ranks will be deduced, ranging from a fine granularity at species and strain level to a more 'zoomed out' phylum level. The richness and diversity of the microbiome (genes and species) will be described. The functional modules, corresponding to the metabolic pathways encoded by the species detected in each sample, will be determined.

次要结局

  • Study the variations in the gut microbiota as a function of microbial profile(5 up to 15 years)
  • Study the variations in the gut microbiota as a function of age(5 up to 15 years)
  • Study the variations in the gut microbiota as a function of socio-demographic and anthropometric characteristics(5 up to 15 years)
  • Study the variations in the gut microbiota as a function of lifestyle and eating habits(5 up to 15 years)
  • Study the variations in the gut microbiota as a function of presence of known pathologies at inclusion, occurrence during follow-up of certain pathologies identified by analysis of data from health from health questionnaires and SNDS data.(5 up to 15 years)

研究者

研究点 (1)

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