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

University Hospital, Rouen

Status and phase: Completed; Phase 3

Conditions: Anal Incontinence

Treatments: Drug: CArbosylane; Drug: Metronidazole

Study type: Interventional

Funder types: Other

Identifiers

NCT01275560

2008/073/HP

Details and patient eligibility

About

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

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Metronidazole

Experimental group

Description:

3 intakes per day during 10 days

Treatment:

Drug: Metronidazole

Carbosylane

Active Comparator group

Description:

3 intakes per daysduring 10 days

Treatment:

Drug: CArbosylane