Clinical trial NCT00331994: EFESO - EFficacy Enterogermina Small Intestinal Bacterial Overgrowth
Official title: Efficacy Evaluation of Enterogermina, 2 Billion Bacillus Clausii Spores, on Eradication of Small Intestinal Bacterial Overgrowth: a Randomised, Parallel-group, Open Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Irritable Bowel Syndrome
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-05-31
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: eradication rate of the small intestinal bacterial overgrowth
timeFrame: 30 days after the end of the treatment.
Secondary outcomes:
measure: avoiding recurrence of the small intestinal bacterial overgrowth
timeFrame: 90 days after the end of the treatment.
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Georges Paizis, MD
role: STUDY_DIRECTOR
References: