Phase III, randomized, double blind, parallel groups, clinical trial to evaluate the efficacy and safety of Bacillus clausii versus placebo in the prevention of antibiotic associated diarrhea (AAD) in children - EPIC

Sanofi Aventis Groupe0 个研究点目标入组 660 人开始时间: 2020年7月10日最近更新: 2022年5月16日

研究概览

暂无简介。

•Children must be 3 months to 5 years of age inclusive, at the time of signing the informed consent.
•Children who have to start a short-term (3 to 10 days) treatment with oral antibiotics (broad spectrum beta-lactam AB [amoxicillin-with or without clavulanic acid-, or second and third generation of cephalosporines], or macrolides [erythromycin, clarithromycin, roxithromycin and azithromycin])
•Participant’s legally authorized representative capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 660
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range 0
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 0

•Chronic or acute diarrheal disease at the time of enrollment in the study.
•Immunodeficient children or children under immunosuppressive treatment.
•Children requiring hospitalization.
•Chronic GI problems (e.g., short gut syndrome, inflammatory bowel disease, gastroesophageal reflux).
•Severely malnourished participants (children will be considered as severely malnourished if below 70% of the expected weight for age).
•Chronic diseases of endocrine, cardiovascular, renal or respiratory system or any other clinically significant condition that can jeopardize participant’s condition or study outcomes as judged by the Investigator.
•Treatment with probiotics or prebiotics within a period of 2 weeks before enrollment.
•Use of laxatives within one week before enrollment in the study.
•Oral or intravenous antibiotic treatment within 4 weeks before enrollment in the study.

发起方