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. (see Contacts and Locations)
Verified June 2014 by University Hospital, Rouen
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT01275560
First received: January 11, 2011
Last updated: June 18, 2014
Last verified: June 2014
  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:


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 2015
Estimated Primary Completion Date: February 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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: June 18, 2014
Health Authority: France: National Consultative Ethics Committee for Health and Life Sciences

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 July 26, 2014