EFESO - EFficacy Enterogermina Small Intestinal Bacterial Overgrowth

Sanofi

Status and phase

Completed

Phase 4

Conditions

Irritable Bowel Syndrome

Treatments

Drug: Bacillus clausii

Drug: Metronidazole

Study type

Interventional

Funder types

Industry

Identifiers

NCT00331994

PM_L_0161

EudraCT # : 2005-004934-42

Details and patient eligibility

About

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.

Enrollment

250 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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