A Multi-Center, Double Blind, Randomized, Parallel-Group, Two-Arm Study to Evaluate the Safety and Efficacy of Bacillus Clausii UBBC07 Suspension (BACIPRO) for the Treatment of Acute Diarrhoea in Children of Age 6 Months to 5 Years

nique Biotech Ltd0 个研究点目标入组 119 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1.Children aged between >=6 months and <=5 years
•2.Subjects with clinical diagnosis of acute
•3.Subjects who experienced more than 3 loose stools in the last 24 hours
•4.Subjects with no major illness.
•5.Parents of the subjects willing to give written informed Consent & willing to follow study procedures.
•6.Informed Consent form signed by the subjectâ??s parent/Legally Acceptable Representative or an impartial witness

•1.Children with severe malnutrition (weight for height < 3 SD of WHO charts).
•2.Subjects requiring antibiotics during the study period.
•3.Presence of severe diarrhoea which, in the opinion of the investigator, requires treatment other than investigational product and ORS.
•4. Presence of visible blood in the stool.
•5.Use of probiotics in the previous three weeks, use of antibiotics or any antidiarrhoeal medication in the previous three weeks.
•6.Participated in any clinical trial or used any investigational product in the past 90 days.
•7.Known or expected hypersensitivity to any of the active substances or excipients.
•8.Previous use (within 48 hours) of kaolin, pectin, bismuth subsalicylate, racecadotril, loperamide, atropine and other anticholinergic agents

发起方

nique Biotech Ltd