Pre-analytical Processing of Human Samples for Microbiota Analysis Quality

NCT07452965 | Not Yet Recruiting

• 1 other identifier: RECHMPL24_0309
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Microbiota; Metagenomics; Metabolomics; Culturomics; Standard Operating Procedures

Outcome Measures

Primary Outcomes (1)

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

  Through study completion, an average of 4 months

Secondary Outcomes (2)

• 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

Study Arms (1)

Stool Sampling Arm

EXPERIMENTAL

Other: Stool sampling

Interventions

Stool sampling OTHER

Participants will have to collect a stool sample and submit it within one hour of its emission

Stool Sampling Arm

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and/or female
• Age between 18 and 85 years
• No diagnosed pathology
• Not opposed to following the study procedures

You may not qualify if:

• 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
• 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 refused to participate in the protocol

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

CHU de Montpellier

Montpellier, France, 34295, France

Location

Central Study Contacts

Audrey GABELLE, Pr

CONTACT

+33 4 67 33 60 29; a-gabelle@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: March 5, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-02

Locations

FR (1)