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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
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: January 2011
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Metronidazole
2 arms : one is an antibiotic treatment (Metronidazole) and the other is the conventional treatment (Carbosylane)
 Drug: Metronidazole
Metronidazole,per os,500mg, 3 per day during 10 days
Active Comparator: Carbosylane Drug: CArbosylane

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01275560

Contacts
Contact: Anne-MArie LEROI, PHD 00-2-32-88-80-39 anne-marie.leroi@chu-rouen.fr

Locations
France
Physiology Unit, Hopital Charles Nicolle, 1 rue de Germont Recruiting
Rouen, France, 76031
Contact: Anne-Marie Leroi, phd     00-33-2-32-88-80-39     anne-marie.leroi@chu-rouen.fr    
Principal Investigator: Anne-marie Leroi, PHd            
Sponsors and Collaborators
University Hospital, Rouen
  More Information

No publications provided

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT01275560     History of Changes
Other Study ID Numbers: 2008/073/HP
Study First Received: January 11, 2011
Last Updated: February 14, 2012
Health Authority: 'Institutional Ethical Committee': 'France'

Additional relevant MeSH terms:
Metronidazole
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Anti-Infective Agents
Therapeutic Uses
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on May 21, 2013