Anal IncontinencePhase 3NCT01275560
Does the Negativation of the Glucose Hydrogen Breath Test Come Along With a Reduction of the Symptoms of Gaz Incontinence ?
A Phase 3 study testing Metronidazole and CArbosylane in people with Anal Incontinence, run by University Hospital, Rouen at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anal Incontinence
- What is being tested?
- Metronidazole and CArbosylane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2011to Jun 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Gaz incontinence for more than 3 months
- Afflilied to national health security
- Having read and sign the information letter and consent form
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Physiology Unit, Hopital Charles Nicolle, 1 rue de Germont
Rouen, 76031
About this study
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
- Conditions
- Anal Incontinence
- Being tested
- Metronidazole, CArbosylane
- Medical subject headings
- Encopresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetronidazoleDrug
Metronidazole,per os,500mg, 3 per day during 10 days
CArbosylaneDrug
| Study group | Role | What they receive |
|---|---|---|
| Metronidazole | Experimental | 3 intakes per day during 10 days Receives: Drug: Metronidazole |
| Carbosylane | Active comparator | 3 intakes per daysduring 10 days Receives: Drug: CArbosylane |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of gaz incontinence episodes
Measured: 3 days before randomization and treatement and 3 days after 10 days of treatment (antibiotic or conventionnal treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anal IncontinenceStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01275560
- Sponsor's protocol ID
- 2008/073/HP
- Status last verified
- Apr 2026
- First submitted
- 11 Jan 2011
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 28763464
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Negativation of the Glucose Hydrogen Breath Test Come Along With a Reduction of the Symptoms of Gaz Incontinence ?
- ClinicalTrials.gov ID
- NCT01275560
- Acronym / sponsor ID
- 2008/073/HP
- Conditions
- Anal Incontinence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 12 Jan 2011 (estimated)
- 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metronidazole | Experimental | Drug: Metronidazole3 intakes per day during 10 days |
| Carbosylane | Active comparator | Drug: CArbosylane3 intakes per daysduring 10 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Gaz incontinence for more than 3 months
- Afflilied to national health security
- Having read and sign the information letter and consent form
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| MetronidazoleMetronidazole,per os,500mg, 3 per day during 10 days | Drug | Metronidazole |
| CArbosylane | Drug | Carbosylane |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Results publication: PubMed 28763464Melchior 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.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Metronidazole and CArbosylane in people with Anal Incontinence, run by University Hospital, Rouen 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 3 inclusion and 8 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: finished, as of the sponsor's last update on 15 May 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01275560, which also lists 1 linked publication.
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 15 May 2026; AzTrials last refreshed its copy on 26 Oct 2026.