An Open Labelled Study on Clinical Efficacy of Bacillus Clausii in Management of Acute Diarrhoea in Children
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 1.No. of stools per day after 24 hours of treatment
研究概览
简要总结
Acute gastroenteritis is an infectious syndrome that representsthe first cause of hospitalization in children1.Diarrhea is usuallya symptom of an infection in the intestinal tract, which can be caused by avariety of bacterial, viral and parasitic organisms. Infection is spreadthrough contaminated food or drinking water, or from person-to-person as aresult of poor hygiene2. Diarrhea due to infection is widespread throughoutdeveloping countries. In developing countries, children under 5 years of ageexperience on average three episodes of diarrhea every year3.One outof every five children who die of diarrhea worldwide is an Indian. Repeatedepisodes of diarrhea in children can result in long-term deleterious effects onnutritional status, possibly due to intestinal damage. Each episode deprivesthe child from the basic nutrition necessary for growth. As a result, diarrheais a major cause ofmalnutrition, and malnourished children are more likely tofall ill from diarrhea2.Themanagement of acute diarrhoea consists of the replacement of lost fluid withglucose-electrolyte oral rehydration solution. This solution, however, reducesneither the severity nor the duration of diarrhoea4 but hassubstantial benefit in preventing major morbidities due to dehydration and evenmortality. The need of the hour is such agents which reduces both severity andduration of diarrhoea without any major impact on the motility retardation.
Probiotics are live microbial feed supplements that beneficiallyaffect the host by improving its microbial balance. They are commonly used inthe treatment and prevention of acute diarrhea. The rationale for usingprobiotics in acute infectious diarrhea is based on the assumption that theyact against intestinal pathogens5 through a variety of physiologicaland mechanical hostility to pathogens.
Out of many probiotics available, Bacillus Clausii is found to be beneficial in reducing prevalence,duration and severity of diarrhea6. This study is aimed to evaluateefficacy of Bacillus Clausii intreatment of acute diarrhea in children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 6.00 Month(s) 至 10.00 Year(s)（—）
- 性别
- All
入选标准
- •Children aged between 6 months and 10 years with acute bacterial gastroenteritis or acute viral gastroenteritis.
- •Acute diarrhea for a duration of <3 days.
排除标准
- •Severe dehydration and electrolyte imbalance Presence of systemic infections Children with known immunocomprising morbidities Children with chronic or severe respiratory, cardiovascular, central nervous system, endocrine and other gastrointestinal disorders on clinical examination.
结局指标
主要结局
1.No. of stools per day after 24 hours of treatment
时间窗: 1.No. of stools per day after 24 hours of treatment | 2.No. of stools per day after 48 hours of treatment | 3.Duration of diarrhoea in days
2.No. of stools per day after 48 hours of treatment
时间窗: 1.No. of stools per day after 24 hours of treatment | 2.No. of stools per day after 48 hours of treatment | 3.Duration of diarrhoea in days
3.Duration of diarrhoea in days
时间窗: 1.No. of stools per day after 24 hours of treatment | 2.No. of stools per day after 48 hours of treatment | 3.Duration of diarrhoea in days
次要结局
- 1.No. of episodes of vomiting(2.Changes in Stool consistency from 24 hrs to 48 hrs.)