Efficacy evaluation of Enterogermina, 2 billion Bacillus clausii spores, on eradication of small intestinal bacterial overgrowth a randomised, parallel-group, open study - EFESO

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 312

Inclusion Criteria

Informed consent signed; Subjects aged 18-65; Male and female subjects; IBS patients Rome II criteria with SIBO based on positive lactulose or glucose hydrogen breath test ; Patients able to maintain their usual diet and lifestyle during the course of the study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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, antidiarrhoeic 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the efficacy of Bacillus clausii in the eradication of SIBO small intestinal bacterial overgrowth vs metronidazole, 30 days after the end of treatment.;Secondary Objective: To assess the efficacy of Bacillus clausii vs metronidazole in avoiding recurrence of SIBO, 90 days after the end of the treatment. To assess the efficacy of Bacillus clausii vs metronidazole in improving IBS-related symptoms. To assess the efficacy of Bacillus clausii vs metronidazole in the satisfactory relief of overall IBS symptoms and of abdominal discomfort or pain. To assess the efficacy of Bacillus clausii vs metronidazole in improving IBS quality of life.;Primary end point(s): Eradication rate of SIBO 30 days after the end of the treatment

Secondary Outcome Measures