Probiotics in the Management of Acute Rotavirus Diarrhea in Bolivian Children: Randomized Double-blind, Controlled Trial Using Two Different Preparations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Duration of diarrhea
研究概览
简要总结
The purpose of this study is to determine the effect of probiotics in rotavirus acute diarrhea in children. The investigators will compare the effect of two different probiotics products.
详细描述
Acute diarrhea remains being the second most frequent infectious condition in children, producing a high number of admissions yearly. In children below one year of age, rotavirus represents the main etiologic agent, both in developed and developing countries. In Bolivia, acute diarrhea affects about 30% of the group below 5 years of age. Probiotics appear as one of the alternatives currently under discussion. Also, evidence available suggests that probiotics shorten the time of diarrhea and therefore the time of rotavirus excretion. In daily practice, we are often limited by the type and number of probiotics products locally available; moreover, information about combined products is scarce. With this in mind, in this study we compared the efficacy of two commercially available products.
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
- Double (Care Provider, Investigator)
入排标准
- 年龄范围
- 1 Month 至 23 Months(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Positive stool sample for rotavirus test
排除标准
- •Severe malnourishment
- •Severe dehydration
- •Use of antibiotics, probiotics or nitazoxanide 2 weeks before admission
- •Systemic infections
- •Severe chronic disease
- •Mixed enteric infections besides rotavirus
研究组 & 干预措施
1
This group will receive S. Boulardii Probiotic and Oral rehydration as needed
干预措施: GB (Florestor) (Drug)
2
This group will receive a mixed Probiotic preparation and oral rehydration as needed
干预措施: GRALB (Drug)
3
This group will receive a placebo, and oral rehydration as needed
干预措施: GC (placebo) (Drug)
结局指标
主要结局
Duration of diarrhea
时间窗: within the first 72 hours during hospitalization
次要结局
- Duration of vomiting(the first 72 hours during hospitalization)
- Duration of hospitalization(4 days)
- Duration of fever(the first 72 hours during hospitalization)
