HealthyPREANALYTICSNCT07452965
Pre-analytical Processing of Human Samples for Microbiota Analysis Quality
A study testing Stool sampling in people with Healthy, run by University Hospital, Montpellier at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Stool sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2026to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and/or female
- Age between 18 and 85 years
- No diagnosed pathology
- Not opposed to following the study procedures
Who cannot join
- 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)
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
CHU de Montpellier
Montpellier, France, 34295
Audrey Pr GABELLE, 04 67 33 60 29 ext. +33, a-gabelle@chu-montpellier.fr
Audrey Pr GABELLE, Pr
About this study
Official title: 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):
- 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
- Being tested
- Stool sampling
- Keywords
- Microbiota, Metagenomics, Metabolomics, Culturomics, Standard Operating Procedures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stool samplingOther
Participants will have to collect a stool sample and submit it within one hour of its emission
| Study group | Role | What they receive |
|---|---|---|
| Stool Sampling Arm | Experimental | Not described Receives: Other: Stool sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fecal microbial composition (alpha diversity and beta diversity) obtained by shotgun metagenomic sequencing.
Measured: Through study completion, an average of 4 months
Secondary outcomes (2)
Fecal microbial composition obtained by shotgun metagenomic sequencing
Measured: Through study completion, an average of 4 months
Fecal metabolic composition obtained by mass spectrometry
Measured: Through study completion, an average of 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study startMar 2026 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07452965
- Sponsor's protocol ID
- RECHMPL24_0309
- Acronym
- PREANALYTICS
- Status last verified
- Feb 2026
- First submitted
- 23 Feb 2026
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mastery of the Pre-analytical Phase of Human Control Samples for Quality and Reference Analysis of Microbiota in Clinical Studies
- ClinicalTrials.gov ID
- NCT07452965
- Acronym / sponsor ID
- PREANALYTICS / RECHMPL24_0309
- Conditions
- Healthy
- Keywords
- Microbiota, Metagenomics, Metabolomics, Culturomics, Standard Operating Procedures
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 5 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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):
- 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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stool Sampling Arm | Experimental | Other: Stool sampling |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and/or female
- Age between 18 and 85 years
- No diagnosed pathology
- Not opposed to following the study procedures
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stool samplingParticipants will have to collect a stool sample and submit it within one hour of its emission | Other | Stool Sampling Arm |
Primary outcome
Fecal microbial composition (alpha diversity and beta diversity) obtained by shotgun metagenomic sequencing.
Time frame: Through study completion, an average of 4 months
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
Related trials for Healthy
Not yet recruitingPhase 2
Investigating the Analgesic Potential of (2R,6R)-HNK in Acute Pain in Healthy Volunteers
Healthy Volunteers
RecruitingObservational study
Collection and Analysis of Blood, Bone Marrow, and Buccal Mucosa Samples From Healthy Volunteers
Healthy Volunteers
RecruitingPhase 1
Bioequivalence Study Between YHP2508A and YHR2601 in Healthy Subjects
Healthy Subjects (HS)
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
RecruitingObservational study
Relationship Between Great Toe Strength And Symptoms of Chemotherapy-Induced Peripheral Neuropathy (CIPN)
Chemotherapy-induced Peripheral Neuropathy (CIPN), Healthy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stool sampling in people with Healthy, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Audrey GABELLE, Pr (+33 4 67 33 60 29, a-gabelle@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fecal microbial composition (alpha diversity and beta diversity) obtained by shotgun metagenomic sequencing. (time frame: Through study completion, an average of 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.