Effectiveness of a Microbiome-directed Food to Promote Programmatic and Sustained Nutritional Recovery Among Children With Uncomplicated Acute Malnutrition
Epicentre
7,356 participants
May 2, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria3
- 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 Criteria8
- 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
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
MDF will be provided to children on a weekly basis for children with SAM and bi-weekly basis for children with MAM at the health center until programmatic recovery but not thereafter.
RUTF will be provided to all children on a weekly basis at the health center until programmatic recovery but not thereafter
RUSF will be provided on a biweekly basis at the health center until programmatic recovery but not thereafter
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06382857