Actively Recruiting
Milk Fat Globule Membrane-Enhanced RUTF for Children With Severe Acute Malnutrition
Led by Washington University School of Medicine · Updated on 2025-12-17
1600
Participants Needed
10
Research Sites
114 weeks
Total Duration
On this page
Sponsors
W
Washington University School of Medicine
Lead Sponsor
P
Project Peanut Butter
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Milk Fat Globule Membrane-Enhanced RUTF for Children With Severe Acute Malnutrition
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 6 to 59 months
- Live within the catchment area of a participating clinic
- Have mid-upper arm circumference less than 11.5 cm and/or weight-for-length z-score below -3 and/or bilateral pedal pitting edema
- Willingness to follow all study procedures and availability for the full study duration without plans to move away
You will not qualify if you...
- Signs of complicated severe acute malnutrition such as inability to tolerate RUTF, breathing problems, mental status changes, sepsis, severe dehydration, or need for immediate hospitalization
- Participation in another therapeutic feeding program within the past month
- Known allergy to study food ingredients including peanut, milk, or fish
- Clear developmental delays observed by nursing staff
- Presence of chronic severe medical conditions other than tuberculosis or HIV, like congenital heart disease
AI-Screening
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Trial Site Locations
Total: 10 locations
1
Bandajuma
Bandajuma, Pujehun, Sierra Leone
Actively Recruiting
2
Bandasuma
Bandasuma, Pujehun, Sierra Leone
Actively Recruiting
3
Bendu Malen
Bendu Malen, Pujehun, Sierra Leone
Actively Recruiting
4
Gbondapi
Gbondapi, Pujehun, Sierra Leone
Actively Recruiting
5
Jendema
Jendema, Pujehun, Sierra Leone
Actively Recruiting
6
Potoru
Potoru, Pujehun, Sierra Leone
Actively Recruiting
7
Sahn Malen
Sahn Malen, Pujehun, Sierra Leone
Actively Recruiting
8
Taninahun
Taninahun, Pujehun, Sierra Leone
Actively Recruiting
9
Zimmi
Zimmi, Pujehun, Sierra Leone
Actively Recruiting
10
Static
Pujehun, Sierra Leone
Actively Recruiting
Research Team
M
Mark J Manary, MD
CONTACT
K
Kevin B Stephenson, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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