Effectiveness of a Microbiome-directed Food to Promote Programmatic and Sustained Nutritional Recovery Among Children With Uncomplicated Acute Malnutrition

Effectiveness of a Microbiome-directed Food to Promote Programmatic and Sustained Nutritional Recovery Among Children With Uncomplicated Acute Malnutrition

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.

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/soy flour, banana, peanut)
• Residence outside the study catchment area or in a non-fixed (e.g. nomadic) community