Pre-analytical Processing of Human Samples for Microbiota Analysis Quality
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Stool sampling.
- Who it may be relevant to
- Registry conditions: Healthy. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Mastery of the Pre-analytical Phase of Human Control Samples for Quality and Reference Analysis of Microbiota in Clinical Studies
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.
Interventions
- Other Stool sampling
Participants will have to collect a stool sample and submit it within one hour of its emission
Primary outcome measures
- Fecal microbial composition (alpha diversity and beta diversity) obtained by shotgun metagenomic sequencing. [Time frame: Through study completion, an average of 4 months]
Secondary outcome measures (2)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 1 center
- CHU de Montpellier — Montpellier
Identifiers
NCT: NCT07452965 · RECHMPL24_0309