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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
250
3 bacillus clausii vials/day for one month
3 Metronidazole tablets/day for one week
Sanofi-Aventis Administrative Office
Milan, Italy
eradication rate of the small intestinal bacterial overgrowth
Time frame: 30 days after the end of the treatment.
avoiding recurrence of the small intestinal bacterial overgrowth
Time frame: 90 days after the end of the treatment.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.