Pre-analytical Processing of Human Samples for Microbiota Analysis Quality

N/ANot Yet RecruitingNCT07452965

University Hospital, Montpellier10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Male and/or female * Age between 18 and 85 years * No diagnosed pathology * Not opposed to following the study procedures Exclusion Criteria: * 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

Outcomes

Primary Outcomes

Fecal microbial composition (alpha diversity and beta diversity) obtained by shotgun metagenomic sequencing.

Time frame: Through study completion, an average of 4 months

Secondary Outcomes

Fecal microbial composition obtained by shotgun metagenomic sequencing

Time frame: Through study completion, an average of 4 months

Fecal metabolic composition obtained by mass spectrometry

Time frame: Through study completion, an average of 4 months

Pre-analytical Processing of Human Samples for Microbiota Analysis Quality

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts