RecruitingNot Applicable

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

Sierra Leone1,600 participantsStarted 2025-09-22

Plain-language summary

The goal of this clinical trial is to test the use of milk fat globule membrane (MFGM) in ready-to-use therapeutic food (RUTF) in children with severe acute malnutrition in Sierra Leone. The main questions it aims to answer are: * Will the inclusion of MFGM in RUTF for 6-59-month-old Sierra Leonean children with severe acute malnutrition improve their neurodevelopment? * Will the inclusion of MFGM in RUTF for 6-59-month-old Sierra Leonean children with severe acute malnutrition reduce its worst consequences: death, hospitalization, and remaining severely malnourished despite treatment? Researchers will compare the MFGM-containing RUTF to standard RUTF, which contains skim milk powder. Participants will: * undergo measurement of length, weight, mid-upper arm circumference, and nutritional edema assessment every two weeks during severe malnutrition treatment * be treated with either MFGM-RUTF or standard RUTF at a dose of 2 sachets per day for up to 12 weeks * undergo neurodevelopmental testing using the Malawi Developmental Assessment Tool at the end of SAM treatment and 6 months later * a subset of participants will undergo blood spot collection and stool sample collection

Who can participate

Age range

6 Months – 59 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 therapeutic 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Malawi Developmental Assessment Tool global z-score

Timeframe: 6 (5-7) months after SAM treatment completion

Composite of poor severe acute malnutrition treatment outcomes

Timeframe: 2-12 weeks of therapeutic feeding

Trial details

NCT IDNCT06869850

SponsorWashington University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-01

Contact for this trial

Mark J Manary, MD

+1 314-454-2341 manarymj@wustl.edu

View on ClinicalTrials.gov More Severe Acute Malnutrition trials