Effectiveness of a Microbiome-directed Food to Promote Programmatic and Sustained Nutritional Recovery Among Children With Uncomplicated Acute Malnutrition
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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/