RecruitingNot ApplicableNCT06869850

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

MFGM-EnhaNceD RUTF for Children With SAM


Sponsor

Washington University School of Medicine

Enrollment

1,600 participants

Start Date

Sep 22, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 6 MonthsMax Age: 59 Months

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Amoxicillin, MFGM-RUTF (milk fat globule membrane ready-to-use therapeutic food), and others for people with cognitive impairment, kwashiorkor, and other related conditions. The study is currently recruiting participants at 10 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTMFGM-RUTF (milk fat globule membrane ready-to-use therapeutic food)

MFGM whey protein/fat concentrate powder used in place of skim milk powder in peanut paste-based ready-to-use therapeutic food meeting Codex Alimentarius specifications. There will be 10g of MFGM-containing whey protein/fat concentrate powder per 100g of MFGM-RUTF. Other ingredients and amounts per 100g: 9.5g rice flour, 5g whey permeate, 18.5g palm oil, 31g peanut paste, 22.1g sugar, 2.9g micronutrient mix, 1g fish oil.

DIETARY_SUPPLEMENTS-RUTF (standard ready-to-use therapeutic food)

Standard peanut paste-based ready-to-use therapeutic food made with skim milk powder meeting Codex Alimentarius specifications. This RUTF is modeled on the most widely used recipe worldwide, containing per 100g: 19.5g skim milk powder, 9.3g palm oil, 7g canola oil, 31.3g peanut paste, 28g sugar, 1g soy flakes, 1g hydrogenated vegetable oil, and 2.9g micronutrient mix.

DRUGAmoxicillin

Oral amoxicillin tablets twice per day for 7 days dosed based on weight

DRUGSulfadoxine (12.5 mg)/Pyrimethamine (250 mg)

Malaria chemoprophylaxis, dosed by weight, to be given every month during SAM treatment


Locations(10)

Bandajuma

Bandajuma, Pujehun, Sierra Leone

Bandasuma

Bandasuma, Pujehun, Sierra Leone

Bendu Malen

Bendu Malen, Pujehun, Sierra Leone

Gbondapi

Gbondapi, Pujehun, Sierra Leone

Jendema

Jendema, Pujehun, Sierra Leone

Potoru

Potoru, Pujehun, Sierra Leone

Sahn Malen

Sahn Malen, Pujehun, Sierra Leone

Taninahun

Taninahun, Pujehun, Sierra Leone

Zimmi

Zimmi, Pujehun, Sierra Leone

Static

Pujehun, Sierra Leone

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NCT06869850


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