- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01275560
Does the Negativation of the Glucose Hydrogen Breath Test Come Along With a Reduction of the Symptoms of Gaz Incontinence ?
May 12, 2026 updated by: University Hospital, Rouen
The objectives of this work are: 1/to estimate the frequency of a positive glucose breath test in favour of a small intestinal bacterial overgrowth in a population of patients consulting for gaz incontinence by comparison to a population of control subjects; 2/to estimate versus a conventional treatment the efficiency of an antibiotic treatment; in case of small intestinal bacterial overgrowth diagnosed by the glucose breath test, to improve gaz incontinence
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Rouen, France, 76031
- Physiology Unit, Hopital Charles Nicolle, 1 rue de Germont
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Gaz incontinence for more than 3 months
- Afflilied to national health security
- Having read and sign the information letter and consent form
Exclusion Criteria:
- Pregnancy
- use of antibiotics, probiotics, IPP for less tha n 3 months
- past of small intestinal bacterial overgrowth
- ischemic, inflammatory colitis,colo-rectal cancer
- diabetes
- allergy to metronidazole
- psychiatric disease
- patients who do not speak or read french
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Metronidazole
3 intakes per day during 10 days
|
Metronidazole,per os,500mg, 3 per day during 10 days
|
|
Active Comparator: Carbosylane
3 intakes per daysduring 10 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
number of gaz incontinence episodes
Time Frame: 3 days before randomization and treatement and 3 days after 10 days of treatment (antibiotic or conventionnal treatment
|
3 days before randomization and treatement and 3 days after 10 days of treatment (antibiotic or conventionnal treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2011
Primary Completion (Actual)
June 1, 2015
Study Completion (Actual)
June 1, 2015
Study Registration Dates
First Submitted
January 11, 2011
First Submitted That Met QC Criteria
January 11, 2011
First Posted (Estimated)
January 12, 2011
Study Record Updates
Last Update Posted (Actual)
May 15, 2026
Last Update Submitted That Met QC Criteria
May 12, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Signs and Symptoms, Digestive
- Behavioral Symptoms
- Elimination Disorders
- Pathological Conditions, Signs and Symptoms
- Behavior
- Signs and Symptoms
- Encopresis
- Organic Chemicals
- Heterocyclic Compounds, 1-Ring
- Heterocyclic Compounds
- Azoles
- Imidazoles
- Nitroimidazoles
- Nitro Compounds
- Metronidazole
Other Study ID Numbers
- 2008/073/HP
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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