Overview

EFESO - EFficacy Enterogermina Small Intestinal Bacterial Overgrowth

Status:
Completed
Trial end date:
2008-07-01
Target enrollment:
0
Participant gender:
All
Summary
Primary objective: to assess the efficacy of Bacillus clausii versus metronidazole in the eradication of the small intestinal bacterial overgrowth, 30 days after the end of treatment. Secondary objective: to assess the efficacy of Bacillus clausii versus metronidazole in avoiding recurrence of the small intestinal bacterial overgrowth, 90 days after the end of the treatment; to assess the efficacy of Bacillus clausiiversus metronidazole in improving irritable bowel syndrome -related symptoms; to assess the efficacy of Bacillus clausii versus metronidazole in the satisfactory relief of overall irritable bowel syndrome symptoms and of abdominal discomfort or pain; to assess the efficacy of Bacillus clausii versus metronidazole in improving irritable bowel syndrome quality of life.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sanofi
Treatments:
Metronidazole
Criteria
Inclusion criteria:

- Irritable bowel syndrome patients with small intestinal bacterial overgrowth (based on
positive lactulose or glucose hydrogen breath test)

- Patients able to maintain their usual diet and lifestyle during the course of the
study.

Exclusion criteria:

- Pregnancy or breast-feeding

- Major concomitant diseases (including tumours and hepatic and/or renal insufficiency)

- Inflammatory bowel diseases

- History of intestinal surgery (except cholecystectomy and appendectomy)

- Use of antibiotic, laxative, antidiarrheic drugs or probiotics (medications or
dietetic supplements) in the last month prior to study entry

- Hypersensibility to the investigational product and reference drug

- Clinical evidence of relevant cardiovascular, respiratory, renal, hepatic,
gastrointestinal, hematologic, neurologic or of any disease that may interfere with
the patient successfully completing the trial or the objectives of the trial

- Eating disorders such as anorexia or bulimia, and/or psychosis, schizophrenia, mania
or major psychiatric illness needing pharmacological treatment. Well-compensated
depression does not exclude a potential patient

- Participation to a trial in the previous three months

- Drug or alcohol abuse

- Subjects with unstable personality or not able to be compliant with the study
procedures

The above information is not intended to contain all considerations relevant to a patient's
potential participation in a clinical trial.