Milk Matters in Malnutrition, is it the Lactose or Dairy Protein?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,102
- 试验地点
- 1
- 主要终点
- % lactulose excretion after 4 weeks of supplementary feeding
研究概览
简要总结
This study is to look at the types of sugar and protein composition in the treatment of moderate acute malnutrition and its effects on gut health. The study will use 4 different types of ready to use supplementary foods to see which one if any has better recovery rate along with looking into the gut health. Children will be treated using one food for up to 12 weeks. A subset of about 400 will be tested for intestinal permeability using the dual sugar test.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The RUSF food products are very similar in appearance and texture; thus, subjects and caretakers will be blinded. The investigators making the clinical assessments will not have information as to specialized food product assignment of the subject, and will remain blinded.
入排标准
- 年龄范围
- 6 Months 至 59 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •MUAC < 12.5 cm and ≥ 11.5 cm without bipedal oedema
排除标准
- •If they are involved in another research trial
- •in another supplemental feeding program
- •debilitating illness
- •history of peanut or milk allergy
结局指标
主要结局
% lactulose excretion after 4 weeks of supplementary feeding
时间窗: 4 weeks
This will only be assessed in children with higher-risk (MUAC \< 12 cm) MAM at baseline. %L measured in the urine relative to the amount ingested will be calculated. %L will be categorized as normal (\<0.2%) and abnormal (\>0.2)
16S rRNA relative abundance of bacterial taxa after 4 weeks of supplementary feeding
时间窗: 4 weeks
This will only be assessed in children with higher-risk (MUAC \< 12 cm) MAM at baseline
次要结局
- Final mid-upper arm circumference(up to 12 weeks of treatment)
- Proportion with %L < 0.20(4 weeks)
- 16S rRNA alpha-diversity at week 4(4 weeks)
- Rate of weight gain (g/kg/d)(up to 12 weeks of treatment)
- Rate of length gain (mm/week)(up to 12 weeks of treatment)
- 16S rRNA beta-diversity at week 4(4 weeks)
- Rate of deteriorating to severe acute malnutrition or death(up to 12 weeks of treatment)
- Sub-group analysis of %L and 16S rRNA outcomes among children not receiving breastfeeding at baseline vs. those being breastfeed at baseline(4 weeks)
- Rate of recovery from moderate acute malnutrition(up to 12 weeks of treatment)
- Sub-group analysis of anthropometric outcomes among children with MUAC < 12 cm vs. >= 12 cm at baseline(up to 12 weeks of treatment)
- Metabolomic feature abundance in the 4 dietary groups(After 4 weeks of supplementary feeding)