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

Anal Incontinence Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01275560
• Other study ID #: 2008/073/HP
• Status: Completed
• Phase: Phase 3
• First received: January 11, 2011
• Last updated: June 2, 2015
• Start date: January 2011
• Est. completion date: June 2015

Study information

• Verified date: June 2015
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: National Consultative Ethics Committee for Health and Life Sciences
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Anal Incontinence
• Fecal Incontinence

Intervention

Drug:
• Metronidazole
Metronidazole,per os,500mg, 3 per day during 10 days
• CArbosylane

Locations

Country	Name	City	State
France	Physiology Unit, Hopital Charles Nicolle, 1 rue de Germont	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of gaz incontinence episodes		3 days before randomization and treatement and 3 days after 10 days of treatment (antibiotic or conventionnal treatment	No