Testing a Microbiome-Directed Food to Help Children 6 to 23 Months Recover from Uncomplicated Acute Malnutrition

What this Trial Is About

Researchers are evaluating the effectiveness of a microbiome-directed food MDF compared to standard nutritional therapy for children aged 6 to less than 24 months who have uncomplicated acute malnutrition. The study aims to assess how well children recover programmatically by 12 weeks after starting treatment and maintain that recovery at 24 weeks. This trial focuses on improving growth and health outcomes in children with moderate or severe acute malnutrition. The study compares two main treatments the experimental microbiome-directed food developed by the International Centre for Diarrhoeal Disease Research, Bangladesh icddr,B, and the standard nutritional foods used for treatment. The MDF includes ingredients like chickpea flour, soy flour, peanut paste, green banana powder, sugar, oil, and micronutrients, provided weekly for severe cases and biweekly for moderate cases until recovery. The standard therapy uses ready-to-use therapeutic foods RUTF and supplements RUSF with similar nutritional components, given on a weekly or biweekly basis depending on malnutrition severity. Participants will be monitored from enrollment through 24 weeks, with assessments including weight gain, growth measurements, motor and cognitive skills, dietary intake, and microbiome and plasma profiles. Recovery and sustained health status will be tracked at specific intervals, including program discharge and final study discharge. Safety will be monitored by recording serious adverse events, hospitalizations, and deaths. Adherence to treatments and cost-effectiveness will also be evaluated during the study period.

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