CTRI/2018/10/016053已完成3 期
A randomized, double blind, placebo controlled, parallel group, multicenter, comparative study to assess the efficacy and safety of spores of Enterogermina in combination with oral rehydration therapy (ORT) and Zinc versus placebo in combination with ORT and Zinc administered for 5 days in the treatment of acute diarrhea in children - KIDDIE
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 457
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1 6 months less or equal to Age less than or equal to 5 years old
- •2 Suffering from acute diarrhea of less than 48 hours duration, Diarrhea is defined as unusual loose or watery stools at least 3 times in previous 24 hours period with no signs of dehydration or some dehydration WHO classification
- •3 Whose parent or legal guardian has given a written informed consent to participate for his or her child in the study at the time of enrollment
排除标准
- •1 Known hypersensitivity to B clausii or any of the excipients or other probiotics
- •2 Children suffering from chronic GI disease as Crohnâ??s disease, hemorrhagic recto colitis, irritable bowel syndrome, short gut syndrome and inflammatory bowel disease
- •3 History of or current presence of blood hematochezia, pus, or mucus in stools within the previous 3 months
- •4 Persistent diarrhea a diarrhea episode which lasts more than 14 days
研究者
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