Use of Probiotic Yogurt in the Treatment of Acute Diarrhea in Children: A Randomized Double-blind Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 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 probiotic yogurt in acute watery diarrhea in children. The investigators will compare the effect of two different probiotics products.
详细描述
Background: Acute Gastroenteritis is one of the most and frequent disease in the childhood, considering the advances in treatment, Lactobacillus Rahmnosus has being well described as a probiotic who reduces the number of days of hospitalization and also de the severity.
Objectives: To evaluate the effect of the probiotic yogurt in the treatment of children who are between 10 months and 3 years old with acute non-dysenteric diarrhea.
Methods: A randomized clinical trial, controlled, double-blind. The investigators will have two groups of patients : One group will receive Lactobacillus Rahmnosus in a yogurt presentation and the other one will receive Sacharomyces boulardii in a lyophilized form ; the parameters of evaluation are going to be the number of diarrhea stools by day, number of vomiting episodes, hours with fever, nutritional and immunization state.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 10 Months 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All acute diarrhea
排除标准
- •Severe malnourishment
- •Severe dehydration
- •Systemic infections
研究组 & 干预措施
probiotic
Probiotic product with Sacharomices Boulardii
干预措施: Placebo probiotic (Drug)
probiotic yogurt
Yogurt with Lactobacilus Rhamnonsus strain spp
干预措施: Probiotic yogurt (Dietary Supplement)
结局指标
主要结局
Duration of diarrhea
时间窗: five days
participants will be followed for the duration of hospital stay, an expected average of 5 days
次要结局
- Duration of fever(five days)
- duration of vomiting(five days)
- duration of hospitalization(five days)
研究者
Carlos Teran
Teaching and Research chief
Centro Pediatrico Albina de Patino