Does Intake of Lactose-free Milk in Infants With Acute Gastroenteritis in a Developing Country Shorten the Duration of Diarrhea? A Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Diarrhea Duration
研究概览
简要总结
The purpose of this study is to determine whether lactose-free milk will shorten the diarrhea duration and decrease its severity in formula-fed infants presenting to the Emergency Department (ED) or pediatric clinics with acute diarrhea.
详细描述
Acute gastroenteritis is a major cause of pediatric morbidity and mortality accounting for 15 % of all childhood death worldwide, and is a major public health burden, especially in developing countries. A recent Cochrane review of 33 randomized or quasi-randomized trials reported a modest reduction in the duration of diarrhea in children younger than 5 years who were on reduced or lactose-free diet. Those trials however were conducted on inpatients in high or middle-income countries. None were from developing countries where diarrheal diseases are severer and result in higher morbidities and mortalities. This study aims at investigating the effect of lactose-free milk on the duration and severity of diarrhea in infants from a developing country, who present with acute gastroenteritis to the Emergency Department (ED) or pediatric clinics. The findings from this study will help provide evidence-based dietary recommendations for infants with acute diarrhea in developing countries who are treated in the ambulatory setting.
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 18 Months(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants on artificial milk formula
- •Presenting to the ED or pediatric clinics of the American University of Beirut Medical Center
- •Chief complaint: acute gastroenteritis (three or more loose or liquid stools in 24 hours, for at least 24 hours, and not exceeding 2 weeks from presentation, with or without fever, vomiting, mucus or blood per stools).
排除标准
- •Exclusively or partially breast-fed infants
- •Severe dehydration requiring hospitalization
结局指标
主要结局
Diarrhea Duration
时间窗: From onset of illness till the day of last diarrheic stool passed.
number of days with 3 or more loose or watery stools
次要结局
- Illness Visits(7 days)
- Parental Satisfaction(7 days)
- Weight Loss(7 days)
- Hospitalization Rate(7 days)
研究者
Mona Nabulsi
Professor of Clinical Pediatrics
American University of Beirut Medical Center
