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

SANOFI-AVENTIS OTC0 个研究点目标入组 312 人开始时间: 2006年6月23日最近更新: 2012年3月19日

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•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

•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

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SANOFI-AVENTIS OTC