Bacillus clausii in the treatment of acute community–acquired diarrhea among Latin American children (cadiLAc) - cadiLAc

Sanofi0 个研究点目标入组 759 人开始时间: 2016年8月26日最近更新: 2016年8月29日

适应症

试验速览

暂无简介。

•Infants or children with acute community-acquired diarrhea (=3 liquid or watery stools occurring in a 24-hour period):
•with less than 48 hours duration
•aged between 6 months and 5 years of age
•whose parents or legal guardians have given their written informed consent
•with clinical indication for ORT per formula of World Health Organization
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 642
•F.1.2 Adults (18-64 years) no
•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

•Infants or children with:
•presence of blood, pus, or mucus in stools
•severe dehydration
•untreatable vomiting
•antibiotics indication for the treatment of this acute diarrhea;
•hospitalization
•expected hospitalization for the next hours due to the poor clinical conditions
•treatment with antibiotics, probiotics, or prebiotics within a period of 2 weeks before enrolment (the use of probiotics and prebiotics in dairy food such as yoghurt, cheese, milk prior to the study is permitted)
•previous use (within 48 hours) of kaolin, pectin, bismuth subsalicylate, racecadotril, loperamide, atropine and other anticholinergic agents
•indication of any other ORT different from the one prescribed in the study
•chronic diseases including chronic diarrhea
•immunodeficiency (acquired or congenital immunodeficiency)
•other infectious comorbid conditions
•known hypersensitivity to Bacillus clausii (Enterogermina) or other probiotics
•parent/legal guardian who, in the opinion of the Investigator, is unable to complete the patient diary or bring the child for the follow-up visit
•participation in another clinical trial in the last 3 months prior to the start of the study.
•The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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