Efficacy of a Food Targeting the Microbiota for a Sustained Recovery of Children With Uncomplicated Acute Malnutrition
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 6,200
- 试验地点
- 1
- 主要终点
- Sustained recovery defined by WHZ ≥ - 2 z-score or MUAC ≥ 125 mm
研究概览
简要总结
The goal of this experimental study is to test the efficacy of a new formulation - The microbiome-directed food (MDF) to treat acute malnutrition among children aged 6 to 23 months. The main questions are:
- Does treating children with moderate or severe uncomplicated malnutrition using MDF leads to higher programmatic recovery rate compared to standard of care ?
- Does treating children with moderate or severe uncomplicated malnutrition using MDF leads to higher sustained recovery rate compared to standard of care ? The MDF will be compared to Ready-to-use supplementary food (RUSF) for moderately malnourished children, and to Ready-to-use therapeutic food (RUTF) for severely malnourished children to see the effects on recovery and sustained recovery rate.
详细描述
In this stratified trial, children presenting at the health center and fulfilling the inclusion criteria will be randomly allocated into one of the study groups in a ratio of 1:1:1 for MAM and 1:1 for SAM.
The supplementation will be done on daily basis according to the child's weight for a maximum of 12 weeks, at which point the programmatic recovery assessment is done. Those who recovered before or at this point, will be subsequently followed up monthly up to 3 month for sustained recovery assessment.
Follow-up visits will be done at the health center every week for severe acute malnutrition (SAM) children and every two weeks for moderate acute malnutrition (SAM) children.
At each visit, anthropometric measurements will be performed; a morbidity questionnaire will be administered before the mother/caregiver receives the ration for the following period. For the measurement of adherence, mothers will be asked to bring back empty and unused sachets/packaging of supplements from the last visit. Questions will also be asked to the mother/caregiver on the difficulties encountered during consumption and the adverse events observed following the consumption of the supplements.
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
- 6 Months 至 23 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 6 and 23 months
- •Moderate wasting: WHZ < -2 and ≥ -3 or MUAC < 125 mm and ≥ 115mm or - Severe wasting: WHZ < -3 or MUAC < 115 mm
排除标准
- •Bilateral pitting edema
- •Not eating/lack of appetite
- •Current illness medical complications requiring inpatient treatment
- •Presence of any congenital abnormality or underlying chronic disease that may affect growth or risk of infection
- •Known contraindication/hypersensitivity/allergy to MDCF of RUSF ingredients (chickpea flour, soy flour, banana, peanut)
- •Relapse from MAM treatment or transfer from SAM treatment
- •Children recently (<2 months) or enrolled in a nutrition program
- •Residence outside the study area
结局指标
主要结局
Sustained recovery defined by WHZ ≥ - 2 z-score or MUAC ≥ 125 mm
时间窗: 24 weeks from admission to the supplementation program
Children who sustain recovery (WHZ ≥ - 2 z-score or MUAC ≥ 125 mm) up to 24 weeks
Programmatic recovery defined by Weight-for-height (WHZ) ≥ - 2 z-score or mid-upper arm circumference (MUAC) ≥ 125 mm
时间窗: 12th weeks from admission to the supplementation program
Moderate cute malnutrition is defined by Weight-for-height (WHZ) \< - 2 z-score or mid-upper arm circumference (MUAC) \< 125 mm. Higher WHZ z-score (≥ - 2) or mid-upper arm circumference (MUAC) ≥ 125 mm means better outcome synonym of recovery
次要结局
- Mean change in Weight-for-age (WAZ) z-score(12 weeks from admission to the supplementation program)
- Mean change in Height-for-age (HAZ) z-score(12 weeks from admission to the supplementation program)
- Time to recovery(Up to 12 weeks)
- Failure(up to 12 weeks)
- Mean change in Weight-for-height (WHZ) z-score(12 weeks from admission to the supplementation program)
- Non-response defined by WHZ < -2 z-score, or a MUAC < 125 mm(12 weeks)
- Complications(up to 12 weeks)
- Dropouts(12 weeks)
研究者
Hermann Lanou
Principal Investigator
Institut de Recherche en Sciences de la Sante, Burkina Faso