Prospective Double Blinded Randomized Clinical Trial of Alanyl-Glutamine or Glycine in Children With Persistent Diarrhea or Malnutrition
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 入组人数
- 108
研究概览
简要总结
This is a double blinded randomized clinical trial of Alanyl-Glutamine or Glycine in children with persistent diarrhea or malnutrition. The primary objective of the study is to determine the effect of 7 days of supplementation of alanyl-glutamine as it compares to glycine on the damaged intestinal barrier function, measured by lactulose/mannitol test on day 8, in children at HIAS in Fortaleza, Ce, Brazil, with persistent diarrhea (history > 2 weeks duration) or malnutrition.
详细描述
This is a double blinded randomized clinical trial of Alanyl-Glutamine or Glycine in children with persistent diarrhea or malnutrition. The primary objective of the study is to determine the effect of 7 days of supplementation of alanyl-glutamine as it compares to glycine on the damaged intestinal barrier function, measured by lactulose/mannitol test on day 8, in children at HIAS in Fortaleza, Ce, Brazil, with persistent diarrhea (history > 2 weeks duration) or malnutrition (assessed by height-for-age Z-score less than -1). Secondary objectives of the study include determining the effect of 7 days of supplementation of alanyl-glutamine or glycine on diarrhea frequency and duration; weight gain; protein loss and intestinal inflammation, and lactoferrin excretion; and weight gain at 2-4 weeks after treatment. One hundred and eight children who meet the inclusion criteria will be prospectively randomized to one of two treatment groups: (1) Glycine or (2) Alanyl-Glutamine. All children will be given vitamin A and Zinc supplementation; and if they have diarrhea, standard oral or IV rehydration therapy will be administered.
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
- Double
入排标准
- 年龄范围
- 3 Months 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children ages 3 to 36 months with a history of persistent diarrhea (3 or more unformed stools/day) for > 2 weeks or height-for-age Z-score (HAZ) less than -1, which is the median of HAZ scores in children at HIAS.
- •Be an inpatient and willing to stay for 7 nights at HIAS.
- •Child's parent or guardian must sign informed consent.
排除标准
- •Children exclusively breast-fed (Reason: The diet needs to be controlled in order to evaluate the study treatment effect)
- •Children who participated in the "community study" or any other study within the past two years (Reason: The children in the "community study" will have received glutamine.)
- •Children with suspected other illnesses as indicated by fever >102 degrees F at time of screening off antipyretics.
- •Children with suspected systemic disease at the time of screening including but not limited to shock, meningitis, sepsis, pneumonia, tuberculosis, varicella
- •Severe malnutrition defined as HAZ <-3.