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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 is currently recruiting participants.
Verified February 2012 by University Hospital, Rouen
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT01275560
First received: January 11, 2011
Last updated: February 14, 2012
Last verified: February 2012
History of Changes

January 11, 2011
February 14, 2012
January 2011
February 2013   (final data collection date for 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01275560 on ClinicalTrials.gov Archive Site
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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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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
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Anal Incontinence
  • Drug: Metronidazole
    Metronidazole,per os,500mg, 3 per day during 10 days
  • Drug: CArbosylane
  • Experimental: Metronidazole
    2 arms : one is an antibiotic treatment (Metronidazole) and the other is the conventional treatment (Carbosylane)
    Intervention: Drug: Metronidazole
  • Active Comparator: Carbosylane
    Intervention: Drug: CArbosylane
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
August 2013
February 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact: Anne-MArie LEROI, PHD 00-2-32-88-80-39 anne-marie.leroi@chu-rouen.fr
France
 
NCT01275560
2008/073/HP
Yes
University Hospital, Rouen
University Hospital, Rouen
Not Provided
Not Provided
University Hospital, Rouen
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP