Pre-analytical Processing of Human Samples for Microbiota Analysis Quality (PREANALYTICS)

February 27, 2026 updated by: University Hospital, Montpellier

Mastery of the Pre-analytical Phase of Human Control Samples for Quality and Reference Analysis of Microbiota in Clinical Studies

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
    • France
      • Montpellier, France, France, 34295
        • CHU de Montpellier
        • Contact:
        • Principal Investigator:
          • Audrey Pr GABELLE, Pr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stool Sampling Arm
Other: Stool sampling
Participants will have to collect a stool sample and submit it within one hour of its emission

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fecal microbial composition (alpha diversity and beta diversity) obtained by shotgun metagenomic sequencing.
Time Frame: Through study completion, an average of 4 months
Through study completion, an average of 4 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Fecal microbial composition obtained by shotgun metagenomic sequencing
Time Frame: Through study completion, an average of 4 months
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
Through study completion, an average of 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

February 23, 2026

First Submitted That Met QC Criteria

February 27, 2026

First Posted (Actual)

March 5, 2026

Study Record Updates

Last Update Posted (Actual)

March 5, 2026

Last Update Submitted That Met QC Criteria

February 27, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RECHMPL24_0309

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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