Irritable Bowel SyndromeMETHANOBIOTENCT06801184
Single-center Exploratory Study of the Intestinal Microbiota in Patients Treated for Irritable Bowel Syndrome With Predominant Constipation and Methane Production
An observational study of Irritable Bowel Syndrome, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Plasma Sample and Stool Sample
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 10 Feb 2025to 10 Oct 2028
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with constipation-predominant irritable bowel syndrome who are methane producers suffering from constipation, attending the digestive functional explorations department for a prescribed breath test as part of an outpatient procedure or gut health workshop session.
Who may be able to join
- 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):
- 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 cannot join
- 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.
Show all 12Show fewer
- 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
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, 1 recruiting
- Recruiting
Hôpital Edouard Herriot
Lyon, 69007
François MION, Pr, 4 72 11 01 36 ext. +33, francois.mion@chu-lyon.fr
About this study
Official title: Single-center Exploratory Study of the Intestinal Microbiota in Patients Suffering of Irritable Bowel Syndrome With Predominant Constipation and Methane Production: METHANOBIOTE
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.
Read more
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:
- 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.
- 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.
- 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.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Plasma Sample, Stool Sample
- Keywords
- gastroenterology, microbiota, Irritable Bowel Syndrome, constipation, methano-production
- Medical subject headings
- Irritable Bowel Syndrome, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma SampleBiological
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).
Stool SampleBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| IBS patients with constipation and methane production | IBS patients with constipation and methane production Receives: Biological: Plasma Sample; Biological: Stool Sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of the initial composition (sequencing of the 16S rRNA gene) of the fecal microbiota in IBS patients with constipation and methane production.
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.
Measured: within 2 months from the first evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start10 Feb 2025
- Primary completion10 Oct 2028 (estimated)
- Study completion10 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06801184
- Sponsor's protocol ID
- 69HCL24_0267
- Acronym
- METHANOBIOTE
- Status last verified
- Jul 2026
- First submitted
- 13 Jan 2025
- Last updated
- 27 Jul 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 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-center Exploratory Study of the Intestinal Microbiota in Patients Suffering of Irritable Bowel Syndrome With Predominant Constipation and Methane Production: METHANOBIOTE
- ClinicalTrials.gov ID
- NCT06801184
- Acronym / sponsor ID
- METHANOBIOTE / 69HCL24_0267
- Conditions
- Irritable Bowel Syndrome
- Keywords
- gastroenterology, microbiota, Irritable Bowel Syndrome, constipation, methano-production
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- 10 Oct 2028 (estimated)
- Study completion
- 10 Oct 2028 (estimated)
- First posted
- 30 Jan 2025 (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.
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:
- 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.
- 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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IBS patients with constipation and methane production | – | Biological: Plasma Sample, Biological: Stool SampleIBS patients with constipation and methane production |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with constipation-predominant irritable bowel syndrome who are methane producers suffering from constipation, attending the digestive functional explorations department for a prescribed breath test as part of an outpatient procedure or gut health workshop session.
Key inclusion criteria (7 listed)
- 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):
- 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.
Key exclusion criteria (12 listed)
- 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.
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 |
|---|---|---|
| Plasma SampleA 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). | Biological | IBS patients with constipation and methane production |
| Stool SampleApproximately 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. | Biological | IBS patients with constipation and methane production |
Primary outcome
Analysis of the initial composition (sequencing of the 16S rRNA gene) of the fecal microbiota in IBS patients with constipation and methane production.
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.
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 27 Jul 2026.
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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?
An observational study of Irritable Bowel Syndrome, run by Hospices Civils de Lyon 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 7 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 27 Jul 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 François MION, Pr (4 72 11 01 36 ext. +33, francois.mion@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of the initial composition (sequencing of the 16S rRNA gene) of the fecal microbiota in IBS patients with constipation and methane production. (time frame: within 2 months from the first evaluation). 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 27 Jul 2026.