EFESO - EFficacy Enterogermina Small Intestinal Bacterial Overgrowth

Irritable Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00331994
• Other study ID #: PM_L_0161
• Secondary ID: EudraCT # : 2005
• Status: Completed
• Phase: Phase 4
• First received: May 30, 2006
• Last updated: July 17, 2009
• Start date: April 2006
• Est. completion date: July 2008

Study information

• Verified date: July 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Irritable Bowel Syndrome

Intervention

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

Locations

Country	Name	City	State
Italy	Sanofi-Aventis Administrative Office	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	eradication rate of the small intestinal bacterial overgrowth		30 days after the end of the treatment.	No
Secondary	avoiding recurrence of the small intestinal bacterial overgrowth		90 days after the end of the treatment.	No