To evaluate the efficacy of probiotic supplements for infants and children in the management of acute diarrhea in a tertiary care hospital in South India
概览
- 阶段
- 4 期
- 状态
- Other (Terminated)
- 发起方
- JHAVER Research Foundation
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Measure of
概览
简要总结
The study titled “ To evaluate the efficacy of probiotics supplements for infants and children in the management of acute diarrhea in a tertiary care hospital in south India†is Terminated and recruitment not done.
Reason: The sponsor insisted on sharing of raw data for publication which can promote the product (which turns it as regulatory trial). The IEC Chengalpattu medical college is registered for conducting of Academic trials only.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 6.00 Month(s) 至 5.00 Year(s)（—）
- 性别
- All
入选标准
- •Children of either sex aged 6 months to 5 years suffering from acute diarrhea with moderate dehydration (duration < 3days).
排除标准
- •Children with history of malabsorption syndromes.
- •Children with hypersensitivity to any of the components.
结局指标
主要结局
Measure of
时间窗: 5 days study period
Number of episodes (frequency) of diarrhea in a day
时间窗: 5 days study period
Mean duration of diarrhea (in days)
时间窗: 5 days study period
Duration and volume of oral rehydration salt [ORS] therapy
时间窗: 5 days study period
Duration and volume of intravenous fluid [IVF] therapy
时间窗: 5 days study period
Consistency of stool by Bristol stool scale.
时间窗: 5 days study period
次要结局
- secondary outcome will be assessed by the occurrence of adverse events (if worsening of existing symptoms, hypersensitivity reactions) following the administration of probiotics and if any will be notified to the IPC and will be uploaded in Vigiflow.(Parental satisfaction on a Likert scale through parental interviews after examining their daily records will be maintained in the diary)
研究者
Dr Elavarasi R
CHENGALPATTU MEDICAL COLLEGE