Status:
COMPLETED
EFESO - EFficacy Enterogermina Small Intestinal Bacterial Overgrowth
Lead Sponsor:
Sanofi
Conditions:
Irritable Bowel Syndrome
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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 objec...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT00331994
Start Date
April 1 2006
End Date
July 1 2008
Last Update
July 20 2009
Active Locations (1)
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1
Sanofi-Aventis Administrative Office
Milan, Italy