This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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.
Information provided by (Responsible Party):
University Hospital, Rouen Identifier:
First received: January 11, 2011
Last updated: June 2, 2015
Last verified: June 2015
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: 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


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
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 identifier: 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 Identifier: NCT01275560     History of Changes
Other Study ID Numbers: 2008/073/HP
Study First Received: January 11, 2011
Last Updated: June 2, 2015

Additional relevant MeSH terms:
Fecal Incontinence
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents processed this record on June 26, 2017