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Does the Negativation of the Glucose Hydrogen Breath Test Come Along With a Reduction of the Symptoms of Gaz Incontinence ?

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: January 12, 2011
Last Update Posted: June 3, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
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

Condition Intervention Phase
Anal Incontinence Drug: Metronidazole Drug: CArbosylane Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • 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 ]

Enrollment: 16
Study Start Date: January 2011
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Metronidazole
3 intakes per day during 10 days
Drug: Metronidazole
Metronidazole,per os,500mg, 3 per day during 10 days
Active Comparator: Carbosylane
3 intakes per daysduring 10 days
Drug: CArbosylane


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01275560

Physiology Unit, Hopital Charles Nicolle, 1 rue de Germont
Rouen, France, 76031
Sponsors and Collaborators
University Hospital, Rouen
  More Information

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT01275560     History of Changes
Other Study ID Numbers: 2008/073/HP
First Submitted: January 11, 2011
First Posted: January 12, 2011
Last Update Posted: June 3, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Fecal Incontinence
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents