MFGM-EnhaNceD RUTF for Children With SAM

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Drug, Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6 months
Maximum Age: 4
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Sierra Leone
Bandajuma
RECRUITING
Bandajuma
Bandasuma
RECRUITING
Bandasuma
Bendu Malen
RECRUITING
Bendu Malen
Gbondapi
RECRUITING
Gbondapi
Jendema
RECRUITING
Jendema
Potoru
RECRUITING
Potoru
Static
RECRUITING
Pujehun
Sahn Malen
RECRUITING
Sahn Malen
Taninahun
RECRUITING
Taninahun
Zimmi
RECRUITING
Zimmi
Contact Information
Primary
Mark J Manary, MD
manarymj@wustl.edu
+1 314-454-2341
Backup
Kevin B Stephenson, MD
k.stephenson@wustl.edu
+1-314-749-8849
Time Frame
Start Date: 2025-09-22
Estimated Completion Date: 2027-12-01
Participants
Target number of participants: 1600
Treatments
Experimental: MFGM-RUTF (Milk fat globule membrane ready-to-use therapeutic food)
One sachet contains 92g of MFGM-RUTF. During SAM treatment, each participant will be given sufficient MFGM-RUTF to consume 2 sachets per day, which will provide approximately 1000 calories, 27g of protein, 63g of fat, and over 1 RDA of micronutrients.
Active_comparator: S-RUTF (standard ready-to-use therapeutic food)
One sachet contains 92g of S-RUTF. During SAM treatment, each participant will be given sufficient S-RUTF to consume 2 sachets per day, which will provide approximately 1000 calories, 27g of protein, 60g of fat, and over 1 RDA of micronutrients.
Related Therapeutic Areas
Sponsors
Collaborators: Project Peanut Butter, Arla Food Ingredients Group P/S, The Danish Dairy Research Foundation, Denmark, Ministry of Health and Sanitation, Sierra Leone
Leads: Washington University School of Medicine

This content was sourced from clinicaltrials.gov