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

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ClinicalTrials.gov Identifier: NCT01275560
Recruitment Status : Completed
First Posted : January 12, 2011
Last Update Posted : June 3, 2015
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen

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

Condition or disease Intervention/treatment Phase
Anal Incontinence Drug: Metronidazole Drug: CArbosylane Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2011
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 ]


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

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

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


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

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT01275560     History of Changes
Other Study ID Numbers: 2008/073/HP
First Posted: January 12, 2011    Key Record Dates
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
Metronidazole
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents