Skip to content

Pre-analytical Processing of Human Samples for Microbiota Analysis Quality

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07452965
Acronym
PREANALYTICS
Enrollment
10
Registered
2026-03-05
Start date
2026-03-01
Completion date
2026-07-01
Last updated
2026-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Microbiota, Metagenomics, Metabolomics, Culturomics, Standard Operating Procedures

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.

Interventions

OTHERStool sampling

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

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Fecal microbial composition (alpha diversity and beta diversity) obtained by shotgun metagenomic sequencing.Through study completion, an average of 4 months

Secondary

MeasureTime frame
Fecal microbial composition obtained by shotgun metagenomic sequencingThrough study completion, an average of 4 months
Fecal metabolic composition obtained by mass spectrometryThrough study completion, an average of 4 months

Countries

France

Contacts

CONTACTAudrey GABELLE, Pr
a-gabelle@chu-montpellier.fr+33 4 67 33 60 29

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026