EFESO - EFficacy Enterogermina Small Intestinal Bacterial Overgrowth

Inclusion criteria:

• Irritable bowel syndrome patients with small intestinal bacterial overgrowth (based onpositive lactulose or glucose hydrogen breath test)

• Patients able to maintain their usual diet and lifestyle during the course of thestudy.

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 ordietetic 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 withthe patient successfully completing the trial or the objectives of the trial

• Eating disorders such as anorexia or bulimia, and/or psychosis, schizophrenia, maniaor major psychiatric illness needing pharmacological treatment. Well-compensateddepression 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 studyprocedures The above information is not intended to contain all considerations relevant to a patient'spotential participation in a clinical trial.