About this trial
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
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- MDF
- RUTF
- RUSF
Treatment groups
Sponsors and collaborators
Epicentre
Lead sponsor
Harvard School of Public Health (HSPH)
Sponsor institution
Epicentre, Niger
Collaborator
National Nutrition Direction, Niger
Collaborator
Ministry of Public Health and Social Affairs, Niger
Collaborator
Regional Direction of Public Health, Maradi
Collaborator