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

Plain-language summary

This study examines the gut microbiota in patients with constipation-predominant irritable bowel syndrome and high methane production, using blood and stool samples. It enrolls people aged 18 and older with irritable bowel syndrome who show high methane levels on a glucose breath test. It is a non-phase study and is currently recruiting participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Recruiting

Sponsor

Hospices Civils de Lyon

Intervention

Plasma Sample, Stool Sample

Start date

2/10/2025

Estimated completion

10/10/2026

Countries

France

Related genes

Locations

• Lyon, France

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* Patient suffering from Irritable Bowel Syndrome (IBS) (abdominal pain for the past 6 months occurring on average at least 1 day per week in the last 3 months, with at least 2 of the following criteria: associated with defecation, associated with a change in stool frequency, associated with a change in stool consistency):

  1. Predominant constipation type (IBS-C): Bristol Stool Scale 1-2 ≥ 25% of the time and Bristol Stool Scale 6-7 ≤ 25% of the time
  2. 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
  3. 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.

Exclusion Criteria:

* 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.
* Patient with uncontrolled diabetes.
* Pregnant or breastfeeding women.
* Patient deprived of liberty by a judicial or administrative decision.
* Adult patient under legal protection (guardianship, curators).
* Patient unable to discontinue proton pump inhibitor treatment during the study period