Efficacy of Lactose-free Milk in Treating Acute Gastroenteritis in Infants: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Change in diarrhea duration
研究概览
简要总结
The purpose of this study is to determine whether lactose-free milk will change diarrhea duration and severity in formula-fed infants with acute gastroenteritis presenting to pediatric wards.
详细描述
More than 525 000 children die each year due to diarrheal disease, the second leading cause of death among children under five. Children from Asian countries, including Vietnamese children, frequently have lactose intolerance. In addition, gastroenteritis, specifically rotavirus-induced gastroenteritis, temporarily impairs lactase enzymes in the intestines. In a recent Cochrane review of 33 randomized and quasi-randomized trials, lactose-free diets reduced diarrhea among children younger than 5 years old. These trials, however, involved inpatients in middle-or high-income countries. Neither patient was from a developing country, where diarrheal diseases often cause significant morbidity and mortality. The purpose of this study is to determine whether lactose-free milk will change the duration and severity of diarrhea in Vietnamese infants with acute gastroenteritis.
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
- 2 Months 至 24 Months(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children 2- 24 months old on artificial milk formula
- •Acute diarrhea (3 or more loose or liquid stools per day)
排除标准
- •Used antibiotics within 3 days before admission
- •Breastfeeding
- •Severe dehydration, defined by a need of IV rehydration
- •Malnutrition (weight/height< -3SD)
- •Chronic underlying disease, immunocompromised condition or systemic infection
结局指标
主要结局
Change in diarrhea duration
时间窗: 7 days
llness onset and last diarrhoeal stool (the number of days with 3 or more loose or watery stools)
次要结局
- Weight gain(7 days)
- Severity of diarrhea according to the modified Vesikari score(7 days)
研究者
Rang Nguyen
University of Medicine and Pharmacy of Can Tho
The Women and Children Hospital of An Giang
