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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-23
SponsorEpicentre

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

7,356 Participants
are divided into 2 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