Actively Recruiting
Milk Fat Globule Membrane-Enhanced Ready-to-Use Therapeutic Food for Children With Severe Acute Malnutrition
Led by Washington University School of Medicine · Updated on 2025-12-17
1600
Participants Needed
10
Research Sites
N/A
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
Researchers are evaluating a new formulation of ready-to-use therapeutic food (RUTF) that includes milk fat globule membrane (MFGM) to treat children aged 6 to 59 months with severe acute malnutrition (SAM) in Sierra Leone. The study aims to find out if MFGM-enhanced RUTF can improve neurodevelopment and reduce serious outcomes like death, hospitalization, or remaining severely malnourished compared to standard RUTF containing skim milk powder. This trial is a randomized, blinded, controlled clinical study involving 1600 children across 20 rural sites. Participants will be assigned to receive either MFGM-RUTF or standard RUTF, with both groups consuming 2 sachets daily for up to 12 weeks. Each sachet contains about 92 grams of therapeutic food providing roughly 1000 calories, protein, fat, and micronutrients. Along with RUTF, some children may receive medications such as amoxicillin and malaria chemoprophylaxis as part of their treatment. The treatment period includes fortnightly clinic visits for measurements and assessments. During the study, children will have their length, weight, arm circumference, and nutritional edema measured every two weeks while receiving treatment. Neurodevelopment will be assessed using the Malawi Developmental Assessment Tool (MDAT) at the end of treatment and again 6 months later. A subset of participants will provide blood and stool samples. Researchers will measure outcomes including neurodevelopment scores, survival, hospitalization, and nutritional recovery over periods ranging from 2 weeks to 7 months after treatment.
CONDITIONS
Brief Title
Milk Fat Globule Membrane-Enhanced RUTF for Children With Severe Acute Malnutrition
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 6 and 59 months
- Reside 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 be available for the study duration without plans to move away
You will not qualify if you...
- Signs of complicated severe acute malnutrition needing immediate hospitalization such as inability to tolerate RUTF test dose, breathing difficulties, mental status changes, sepsis, or severe dehydration
- Participation in another therapeutic feeding program within the past month
- Known allergy to peanuts, milk, or fish in the study food
- Clinically evident developmental delay based on nursing assessment
- Presence of a severe chronic medical condition other than tuberculosis or HIV, such as congenital heart disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 weeks
Participants receive two sachets per day of either MFGM-enhanced RUTF or standard RUTF at home, with fortnightly clinic visits for health assessments, anthropometric measurements, and to receive more RUTF until recovery or up to 12 weeks.
Fortnightly visits for up to 12 weeks
Duration - 1 visit at 5 to 7 months after treatment completion
Participants return to the clinic 5 to 7 months after completing treatment for neurodevelopmental assessment using the Malawi Developmental Assessment Tool (MDAT). A subset may provide blood and stool samples at the end of treatment.
1 visit (in-person)
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
K
Kevin B Stephenson, MD
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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