Comparison of WHO Treatment of Acute Watery Diarrhea With or Without Probiotic (Bacillus Clausii) in Term of Mean Duration of Diarrhea in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 184
- 试验地点
- 1
- 主要终点
- Stool frequency
研究概览
简要总结
This study aimed to compare WHO treatment of acute watery diarrhea with or without probiotic (bacillus clausii) in term of mean duration of diarrhea in children
详细描述
Available literature regarding the use of probiotics is not conclusive and contains controversy, and local data is also scarce. Therefore, this study was planned to further explore the use of probiotics to furnish the local data. If significantly less mean duration of diarrhea is noted in the probiotic group, it will help to add probiotic bacillus clausii in routine treatment regimen recommended by WHO and to decrease costs associated with prolonged treatment. However, if otherwise results will be noted it will help to rule out use of probiotic bacillus clausii in children with acute diarrhea to avoid its unnecessary use.
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
- Single (Participant)
入排标准
- 年龄范围
- 6 Months 至 59 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both genders
- •Aged 6 to 59 months
- •Suffering from acute watery diarrhea for ≤ 7 days
排除标准
- •Children with blood in stool
- •With prior antibiotics use
- •Children under study with duration of stay more than 5 days
- •clinical signs of a coexisting acute systemic illness like pneumonia, sepsis, meningitis, severely malnourished
- •Immunocompromised children
- •Hypersensitivity to probiotics
- •With prior probiotic administration
研究组 & 干预措施
Probiotic group
Patients received 2 billion spores of probiotic (Bacillus clausii) every 12 hours, contained in a small bottle along with standard treatment as per WHO guidelines.
干预措施: Probiotic Bacillus Clausii (Drug)
结局指标
主要结局
Stool frequency
时间窗: 5 days
A frequency of defecation of \< 3 stools per day marked the effectiveness of the treatment.
Consistency of stools
时间窗: 5 days
The treatment was considered effective if the consistency of stools became semi-solid.
次要结局
未报告次要终点
研究者
Muhammad Aamir Latif
Research Consultant
RESnTEC, Institute of Research