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临床试验/NCT02246010
NCT02246010终止不适用

Does Intake of Lactose-free Milk in Infants With Acute Gastroenteritis in a Developing Country Shorten the Duration of Diarrhea? A Randomized Clinical Trial.

American University of Beirut Medical Center1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2015年7月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mona Nabulsi

Professor of Clinical Pediatrics

American University of Beirut Medical Center

研究点 (1)

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