Milk Fat Globule Membrane-Enhanced RUTF for Children With Severe Acute Malnutrition

Launched by WASHINGTON UNIVERSITY SCHOOL OF MEDICINE · Mar 5, 2025

Keywords

ClinConnect Summary

This clinical trial is focused on helping young children in Sierra Leone who are severely malnourished. Researchers want to see if adding a special ingredient called milk fat globule membrane (MFGM) to a type of food known as ready-to-use therapeutic food (RUTF) can help improve brain development and reduce serious health problems, like hospitalization or even death, in children aged 6 to 59 months. They will compare the new MFGM-enriched RUTF with regular RUTF that contains skim milk powder to find out which is more effective.

To be part of this study, children must be between 6 and 59 months old and show signs of severe malnutrition, such as being very underweight or having swelling in their feet. Throughout the trial, children will receive either the MFGM-RUTF or the standard RUTF for up to 12 weeks, and their growth and development will be monitored. Parents or guardians should be willing to follow the study's instructions and ensure their child can attend all necessary visits. The study aims to provide important information that could improve treatment for malnourished children in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 6-59 months of age
• • Reside within the catchment area of a participating clinic
• • mid-upper arm circumference \< 11.5 cm and/or weight-for-length z-score \< -3 and/or presence of bilateral pedal pitting edema
• • willingness to comply with all study procedures and availability for the duration of the study, including no plan to move from the catchment area of a participating clinic
• Exclusion Criteria:
• • Features of complicated SAM: inability to tolerate a 30 g test dose of RUTF, breathing difficulties, mental status changes, sepsis, diarrhea with severe dehydration, and/or physician/nursing clinical assessment that the child needs immediate hospitalization
• • Participation in a separate feeding program within the past month
• • Known allergy to study food ingredient (peanut, milk, fish)
• • Clinically evident developmental delay (most often determined based on research nursing assessment of physical appearance, movement, and informal discussion with caregiver)
• • Presence of a chronic severe medical condition (other than tuberculosis and HIV), such as congenital heart disease