EFESO - EFficacy Enterogermina Small Intestinal Bacterial Overgrowth
- Conditions
- Irritable Bowel Syndrome
- Interventions
- Registration Number
- NCT00331994
- Lead Sponsor
- Sanofi
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 250
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Metronidazole - 1 Bacillus clausii -
- Primary Outcome Measures
Name Time Method eradication rate of the small intestinal bacterial overgrowth 30 days after the end of the treatment.
- Secondary Outcome Measures
Name Time Method avoiding recurrence of the small intestinal bacterial overgrowth 90 days after the end of the treatment.
Trial Locations
- Locations (1)
Sanofi-Aventis Administrative Office
🇮🇹Milan, Italy