Hôpital Edouard Herriot
Lyon, 69007, France
Location status: Recruiting
NCT Number: NCT06801184
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.
The etiology of IBS is multifactorial, involving intestinal motility disorders, visceral hypersensitivity, micro-inflammation of the intestinal mucosa, and dysbiosis. It has been demonstrated that the sub-category of IBS patients with constipation predominantly have increased amounts of Methanobrevibacter smithii, the most common methanogenic archaea found in the intestinal lumen, compared to other IBS patients.
Breath tests can evaluate methane production by the intestinal microbiota, indirectly assessing the presence and quantity of methanogenic archaea. The acronym IMO (intestinal methanogen overgrowth) defines the association of digestive symptoms (notably bloating and constipation) with a high concentration of methane in exhaled gases (≥ 10 ppm).
The links between constipation, methane production, and fecal microbiota are uncertain, necessitating further studies that could lead to precise diagnostic and treatment recommendations.
Main objective: Describe the initial composition of the fecal microbiota of constipated methano-producing IBS patients.
Secondary objectives:
2. Describe the initial composition of blood metabolites linked to the microbiota of constipated methano-producing IBS patients 3. Describe the evolution of the fecal microbiota and blood metabolites linked to the fecal microbiota during conventional therapeutic management (before and after) of constipated methano-producing IBS patients.
4. Compare the composition of the fecal microbiota before and after conventional therapeutic management of responding IBS-C patients (-30% on the IBS-SSS symptom severity score) compared to non-responding patients.
5. Evaluate the impact of Methanobrevicter smithii in the response to symptomatic treatment.
Exploratory observational single-center study (cohort follow-up) descriptive in patients with irritable bowel syndrome with constipation (IBS-C, IBS-m or IBS-U) with excessive methane production detected on a glucose breath test.
Patients will be invited to participate once the results of the breath test are known.
Please note:
In the context of this study, only two microbiota samples and 4 additional tubes and one tube of blood will be added to the usual practice. All treatments will be prescribed as part of the care and are not conditioned by the research protocol.
The primary endpoint is the analysis of the initial composition (16S rRNA gene sequencing) of the fecal microbiota of constipated methano-producing IBS patients.
The study population consists of constipated IBS patients with excessive methane production seen in the digestive functional exploration department for a breath test prescribed as part of an external procedure or a day hospital session.
A total of 40 patients will be included over 18 months, with a participation duration of 2 months +/- 2months per subject.
Patients with IBS constitute a heterogeneous population for whom only symptomatic treatment is currently offered with variable and unpredictable efficacy. Through this work, we seek to find new therapeutic axes to relieve or even treat their symptoms.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Lyon, 69007, France
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A peripheral venous blood sample will be collected on the day of the inclusion consultation and during the follow-up consultation at V2. These samples will be collected in a single2 tubes (4 mL and 5 mL)l tube and will be taken simultaneously with routine blood samples, which require 2 tubes (10 3 mL and 4 mLl).
Approximately 1 gram of stool will be collected by the patient at home within 72 hours following the inclusion consultation and the follow-up consultation at V2, using the kits provided along with the instructions. The stools will be immediately collected into two tubes: one tube with nucleic acid preservative and one tube conservative to ensure for future metabolomic analyses. The patient will then send the sample using the pre-paid envelope included in the kit to the HCL microbiota biobank (CRB GHN) for aliquoting and storage at -80°C.
Time frame: within 2 months from the first evaluation
16S rRNA gene sequencing is a molecular technique used to analyze the composition and diversity of microbial communities, such as those found in fecal samples. The 16S rRNA gene is a highly conserved region of bacterial and archaeal genomes, but it also contains hypervariable regions that can be used to distinguish between different species or strains.
Contact information is provided by the study sponsor or research team.
Hospices Civils de Lyon
Other
Single-center Exploratory Study of the Intestinal Microbiota in Patients Suffering of Irritable Bowel Syndrome With Predominant Constipation and Methane Production: METHANOBIOTE
Acronym: METHANOBIOTE
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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