Official Title: “Efficacy Evaluation of Enterogermina, 2 Billion Bacillus Clausii Spores, on Eradication of Small Intestinal Bacterial Overgrowth: a Randomised, Parallel-Group, Open Study.”

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

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: July 2008

Intervention(s) in this Clinical Trial

• Drug: Bacillus clausii
  • 3 bacillus clausii vials/day for one month
• Drug: Metronidazole
  • 3 Metronidazole tablets/day for one week

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Active Comparator: 2

Primary Measures

• eradication rate of the small intestinal bacterial overgrowth
  • Time Frame: 30 days after the end of the treatment.
    Safety Issue?: No

Secondary Measures

• avoiding recurrence of the small intestinal bacterial overgrowth
  • Time Frame: 90 days after the end of the treatment.
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Sanofi-Aventis

Overall Clinical Trial Officials and Contacts

Georges Paizis, MD Study Director Sanofi-Aventis  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00331994

Study ID Number: PM_L_0161

ClinicalTrials.gov Identifier: NCT00331994

Health Authority: Italy: Ministry of Health