RecruitingNot a traditional drug phaseobservationalRules rewrite

Not a traditional drug phase: testing Plasma Sample for Irritable Bowel Syndrome

Irritable Bowel Syndrome (IBS), characterized by the Rome IV criteria, is a functional bowel disorder combining abdominal pain with changes in bowel habits and/or stool consistency. This condition is common, affecting 5% to 10% of the population in developed countries.

Official registry: https://clinicaltrials.gov/study/NCT06801184 · Hospices Civils de Lyon · enrollment listed as 40

What this phase means

This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.

They plan to enroll about 40 people at Lyon. Taking part typically means an infusion or injection of a biologic plus check-ins.

Official title (unrewritten)

Single-center Exploratory Study of the Intestinal Microbiota in Patients Suffering of Irritable Bowel Syndrome With Predominant Constipation and Methane Production: METHANOBIOTE

Interventions: Plasma Sample, Stool Sample

Primary outcome (registry wording): Analysis of the initial composition (sequencing of the 16S rRNA gene) of the fecal microbiota in IBS patients with constipation and methane production.

Who it is for (from inclusion criteria)

Ages 18 Years to any
Predominant constipation type (IBS-C): Bristol Stool Scale 1-2 ≥ 25% of the time and Bristol Stool Scale 6-7 ≤ 25% of the time
Alternating diarrhea-constipation type (IBS-M): Bristol Stool Scale 1-2 25% of the time and Bristol Stool Scale 6-7 25% of the time
Unspecified type: absence of sufficient criteria to meet criteria for IBS-C, IBS-D, or IBS-M
Patient exhibiting a high methane level (≥ 10 ppm) during a glucose breath test
Aged ≥ 18 years at the time of study entry
Patient not opposing participation in the study

Who the registry excludes

Patient who has been treated with antibiotics or probiotics in the last 3 months prior to inclusion
Patient suffering from diarrhea-predominant IBS (Bristol Stool Scale 6-7 ≥ 25% of the time and Bristol Stool Scale 1-2 ≤ 25% of the time)
Patient with a history of abdominal surgery other than appendectomy and cholecystectomy
Patient with a history of celiac disease
Patient with proven inflammatory bowel disease
Patient with a history of colorectal cancer
Patient with uncontrolled hypothyroidism

Public study contact (from the registry)

François MION, Pr

4 72 11 01 36

francois.mion@chu-lyon.fr

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

Hôpital Edouard Herriot — Lyon, France (recruiting)

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FAQ about this NCT record

Is NCT06801184 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06801184?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06801184?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary