Mastery of the Pre-analytical Phase of Human Control Samples for Quality and Reference Analysis of Microbiota in Clinical Studies
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Fecal microbial composition (alpha diversity and beta diversity) obtained by shotgun metagenomic sequencing.
研究概览
简要总结
The goal of this study is to optimise the pre-analytical process for metagenomic analysis of the microbiota in comparison with the current reference technique.
A comparative evaluation will be performed between the following and the reference standard (quickly frozen fresh stool):
i) faecal sample collection devices commonly used in France and abroad for metagenomics, metabolomics and culturomics; ii) self-collection device that would allows the collection of faecal material and the generation of aliquots for all possible omic assessments for research purposes, including metagenomic analysis, as well as culturomics and faecal transfer to animal models.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and/or female
- •Age between 18 and 85 years
- •No diagnosed pathology
- •Not opposed to following the study procedures
排除标准
- •Ongoing digestive neoplasia or < 5 years
- •Digestive surgery with intestinal resection
- •Presence of inflammatory bowel disease or other familial gastrointestinal pathology
- •Chronic use of laxatives
- •Use of antibiotics in the two months prior to inclusion
- •Life-threatening conditions in the short term (progressive cancer, unstable heart failure, severe liver, kidney or respiratory failure)
- •Chronic psychosis or psychotic episodes
- •Alcohol or drug addiction
- •Epilepsy and other non-degenerative diseases of the central nervous system
- •Vitamin B12 and folic acid deficiency not supplemented
- •Untreated hypothyroidism
- •Pregnant or breastfeeding woman
- •Person deprived of liberty by judicial or administrative decision
- •Major protected by law
- •Not affiliated with a social security scheme or beneficiary of such a scheme
- •Having a period of relative exclusion in relation to another protocol
- •Having refused to participate in the protocol
研究组 & 干预措施
Stool Sampling Arm
干预措施: Stool sampling (Other)
结局指标
主要结局
Fecal microbial composition (alpha diversity and beta diversity) obtained by shotgun metagenomic sequencing.
时间窗: Through study completion, an average of 4 months
次要结局
- Fecal microbial composition obtained by shotgun metagenomic sequencing(Through study completion, an average of 4 months)
- Fecal metabolic composition obtained by mass spectrometry(Through study completion, an average of 4 months)