Does the Negativation of the Glucose Hydrogen Breath Test Come Along With a Reduction of the Symptoms of Gaz Incontinence ?
1 other identifier
interventional
16
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jan 2011
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 11, 2011
CompletedFirst Posted
Study publicly available on registry
January 12, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedMay 15, 2026
April 1, 2026
4.4 years
January 11, 2011
May 12, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
number of gaz incontinence episodes
3 days before randomization and treatement and 3 days after 10 days of treatment (antibiotic or conventionnal treatment
Study Arms (2)
Metronidazole
EXPERIMENTAL3 intakes per day during 10 days
Carbosylane
ACTIVE COMPARATOR3 intakes per daysduring 10 days
Interventions
Eligibility Criteria
You may qualify if:
- Gaz incontinence for more than 3 months
- Afflilied to national health security
- Having read and sign the information letter and consent form
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Physiology Unit, Hopital Charles Nicolle, 1 rue de Germont
Rouen, 76031, France
Related Publications (1)
Melchior C, Gourcerol G, Bridoux V, Ducrotte P, Quinton JF, Leroi AM. Efficacy of antibiotherapy for treating flatus incontinence associated with small intestinal bacterial overgrowth: A pilot randomized trial. PLoS One. 2017 Aug 1;12(8):e0180835. doi: 10.1371/journal.pone.0180835. eCollection 2017.
PMID: 28763464RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 11, 2011
First Posted
January 12, 2011
Study Start
January 1, 2011
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
May 15, 2026
Record last verified: 2026-04