NCT06382857招募中不适用
Effectiveness of a Microbiome-directed Food to Promote Programmatic and Sustained Nutritional Recovery Among Children With Uncomplicated Acute Malnutrition
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Epicentre
- 入组人数
- 7,356
- 试验地点
- 1
- 主要终点
- Sustained recovery at 24 weeks from admission
研究概览
简要总结
This study is an individually randomized controlled trial comparing microbiome-directed foods to standard nutritional therapy among children aged 6 to < 24 months with uncomplicated acute malnutrition in terms of programmatic recovery by 12 weeks from admission and sustained recovery at 24 weeks from admission.
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
- •for children with Severe Acute Malnutrition (SAM): MUAC < 115 mm and/or WLZ < -3 and/or mild (+) or moderate (++) edema
- •for children with Moderate Acute Malnutrition (MAM): 115 mm ≤ MUAC < 125 mm and/or -3 ≤ WHZ < -2
- •Caregiver providing informed consent
排除标准
- •Medical complications requiring inpatient treatment, as identified by the national protocol
- •Not eating/lack of appetite (as informed by appetite test and investigator judgement)
- •Re-admission into the program within 2 months of previous default
- •for children with Severe Acute Malnutrition (SAM): Referral from inpatient care (therapeutic feeding center, TFC) or supplementary feeding program (SFP)
- •for children with Moderate Acute Malnutrition (MAM): Referral from SAM treatment (TFC or OTP)
- •Presence of congenital abnormality or underlying chronic disease that may affect growth or risk of infection
- •Known contraindication/ hypersensitivity/allergy to study interventions (chickpea/soy flour, banana, peanut)
- •Residence outside the study catchment area or in a non-fixed (e.g. nomadic) community
结局指标
主要结局
Sustained recovery at 24 weeks from admission
时间窗: 24 weeks
Proportion of recovered SAM and MAM children with WLZ ≥ -2 AND MUAC ≥ 125mm AND no edema
Programmatic recovery by 12 weeks from admission
时间窗: 12 weeks
Defined as the proportion of SAM and MAM children achieving a WLZ ≥ -2 AND MUAC ≥ 125mm AND no edema during 2 consecutive visits
次要结局
- Change in MUAC(From enrollment to 4, 8 and 12 weeks)
- Hospitalization(24 weeks)
- Non-response(12 weeks)
- Time to recovery(12 weeks)
- For MAM children: Deterioration to SAM(24 weeks)
- Change in weight gain(From enrollment to 4, 8 and 12 weeks)
- Change in weight-for-length Z (WLZ)(From enrollment to 4, 8 and 12 weeks)
- Change in weight-for-age Z (WAZ)(From enrollment to 4, 8 and 12 weeks)
- Default(12 weeks)
- Change in length-for-age Z (LAZ)(From enrollment to 4, 8 and 12 weeks)
- Serious adverse events(24 weeks)
- Death(24 weeks)
- Dietary intake(24 weeks)
- Adherence(12 weeks)
- Immuno-sufficiency at week 2, week 4, program discharge, week 12 and study discharge (SAM only)(24 weeks)
- Motor, cognitive, language, social-emotional, and mental health skills(24 weeks)
- Cost effectiveness(24 weeks)
- Microbiome profile at enrollment, week 4, program discharge, and study discharge(24 weeks)
- Plasma proteome profile at enrollment, week 4, program discharge, and study discharge(24 weeks)
- Micronutrient status at enrollment, program discharge and study discharge(24 weeks)
- Environmental enteric dysfunction at enrollment, program discharge, and study discharge(24 weeks)
- Change of fat mass and fat-free mass at program discharge and study discharge(24 weeks)
研究者
Sheila Isanaka
Associate Professor
Harvard School of Public Health (HSPH)
研究点 (1)
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