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临床试验/NCT05634603
NCT05634603招募中不适用

Efficacy of Lactose-free Milk in Treating Acute Gastroenteritis in Infants: A Randomised Controlled Trial

The Women and Children Hospital of An Giang2 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2022年12月1日最近更新:
适应症

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

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

发起方
The Women and Children Hospital of An Giang
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rang Nguyen

University of Medicine and Pharmacy of Can Tho

The Women and Children Hospital of An Giang

研究点 (2)

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