CTRI/2024/01/061370尚未招募3 期
Safety and Efficacy of saccharomyces boulardii (CNCM I-745) in acute diarrhea in children of age 6 months to 5 years.A Randomized Double blind controlled study.
Kumari Akanksha Rani1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2024年1月18日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- 1.To evaluate safety and efficacy of saccharomyces boulardii in acute diarrhea in children of age 6 months to 5 years.
研究概览
简要总结
This study is Randomized Controlled Trial to evaluate safety and efficacy of Saccharomyces Boulardii (CNCM I-745) in acute diarrhea in children of age 6 months to 5 years.Study will be conducted at Geetanjali hospital ,UDAIPUR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 6.00 Month(s) 至 5.00 Year(s)（—）
- 性别
- All
入选标准
- •All the children age between 6 months to 5 years attending out patient department of Pediatrics with diagnosis of acute diarrhea.
排除标准
- •History of presence of blood in stool,Clinical signs of severe malnutrition,Clinical signs of severe dehydration,Treatment with antibiotics/probiotics,Coexisting acute systemic illness.
结局指标
主要结局
1.To evaluate safety and efficacy of saccharomyces boulardii in acute diarrhea in children of age 6 months to 5 years.
时间窗: On day 3 and day 6
次要结局
- To analyse other associated clinical features in acute diarrhea.(on day 3 and day 6)
研究者
Kumari Akanksha Rani
Geetanjali Medical College and Hospital
研究点 (1)
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