Clinical Outcome of Zinc Plus Saccharomyces Boulardii Versus Zinc Alone in the Treatment of Acute Diarrhea in Children Under 5 Years of Age
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 276
- 试验地点
- 1
- 主要终点
- Resolution of vomiting
研究概览
简要总结
In literature combined therapy of zinc with S. boulardii in the treatment of acute diarrhea has not been addressed satisfactorily in the recent past. Therefore, this study was planned aiming to compare the mean time taken to resolve diarrhea and the mean time taken to resolve vomiting in children under 5 years of age having acute diarrhea with zinc plus S. boulardii versus zinc alone.
详细描述
Zinc has been used as a recommended choice treating acute watery ailments among children. If any significant beneficial effect in the combined efficacy of zinc with S. boulardii is found, it may add on to pre-existing knowledge and may lead clinicians to delineate the treatment guidelines to provide more effective treatment to the patients in clinical practices to reduce undesirable morbidity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Month 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children of either gender
- •Aged between 1 month up to 5 years
- •Presented with acute diarrhea
排除标准
- •Children with concurrent acute illnesses (meningitis, sepsis, or pneumonia)
- •Severe chronic conditions (cystic fibrosis, endocrinopathies, food allergies, or chronic gastrointestinal diseases)
- •Severe undernutrition (weight-for-age <60% of the 50th percentile of CDC 2000 standards)
- •Children who used probiotics, antibiotics, or anti-diarrheal drugs within the past 7 days
- •The presence of visible blood in stools
研究组 & 干预措施
Probiotic group
Standard treatment plus S. boulardii
干预措施: S. boulardii (Drug)
结局指标
主要结局
Resolution of vomiting
时间窗: 14 hours
The time from the start of treatment to the last episode of vomiting.
Resolution of diarrhea
时间窗: 7 days
The duration from initiation of treatment until passage of normal stools (Bristol Stool Form Scale types 3-4).
次要结局
未报告次要终点
研究者
Muhammad Aamir Latif
Research Consultant
RESnTEC, Institute of Research