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NCT Number: NCT07452965

Pre-analytical Processing of Human Samples for Microbiota Analysis Quality

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.

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Key information

Conditions

Healthy

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Montpellier

Montpellier, France, 34295

Location contact

Audrey Pr GABELLE

CONTACT

[email protected]

04 67 33 60 29 ext. +33

Audrey Pr GABELLE, Pr

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stool sampling

Other

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

Primary outcomes

  1. 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

  1. Fecal microbial composition obtained by shotgun metagenomic sequencing

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

  2. Fecal metabolic composition obtained by mass spectrometry

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

Study contacts

Contact information is provided by the study sponsor or research team.

Audrey GABELLE, Pr

CONTACT

[email protected]

+33 4 67 33 60 29

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Acronym: PREANALYTICS

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 5, 2026
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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