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临床试验/NCT04334538
NCT04334538已完成不适用

Effect of an Alternative RUTF on Intestinal Permeability in Children With Severe Acute Malnutrition

Washington University School of Medicine1 个研究点 分布在 1 个国家目标入组 129 人开始时间: 2021年3月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
129
试验地点
1
主要终点
Change of % of lactose excreted between enrollment and 4 weeks after enrollment

研究概览

简要总结

Ready-to-use therapeutic food (RUTF) is the standard of care for the treatment of SAM. UNICEF requires that there be no oil separation in these products necessitating the use of emulsifiers. The effect of emulsifiers on gut health and integrity in children receiving an exclusive diet of RUTF is unknown. The PIs have recently completed a randomized, triple-blind, controlled, clinical equivalency trial in Sierra Leone comparing the alternative oat RUTF (oat-RUTF) to standard RUTF on recovery rates in children with SAM. This study demonstrated higher rates of recovery among children receiving the oat-RUTF. The investigators hypothesize that this benefit may be due to the lack of emulsifier in the oat-RUTF resulting in improved intestinal health.This research project is a double-blind, randomized, controlled clinical effectiveness trial comparing a novel RUTF containing oats and no emulsifier and standard RUTF on recovery from severe acute malnutrition (SAM) and effects on intestinal health. The trial will be conducted in up to 40 PHUs in Western Rural and Pujehun Districts where supplementary feeding programs (SFP) are not currently available.

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 (Participant, Care Provider)

入排标准

年龄范围
6 Months 至 59 Months(Child)
性别
All
接受健康志愿者

入选标准

  • mid-upper arm circumference (MUAC) <11.5 cm

排除标准

  • Children currently involved in another research trial or feeding program
  • Children developmentally delayed
  • have a chronic debilitating illness
  • history of peanut or milk allergy

结局指标

主要结局

Change of % of lactose excreted between enrollment and 4 weeks after enrollment

时间窗: at week 4 after enrollment

%L measured in the urine relative to the amount ingested will be calculated for children in both groups. %L will be categorized as normal (\<0.2%) and abnormal (\>0.2)

次要结局

  • fecal 16S rRNA configuration after 4 weeks of feeding(after 4 weeks of feeding)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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