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

NARecruitingINTERVENTIONAL
Enrollment

1,600

Participants

Timeline

Start Date

September 22, 2025

Primary Completion Date

December 1, 2027

Study Completion Date

December 1, 2027

Conditions
Severe Acute MalnutritionCognitive ImpairmentKwashiorkorSevere Wasting
Interventions
DIETARY_SUPPLEMENT

MFGM-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_SUPPLEMENT

S-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.

DRUG

Amoxicillin

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

DRUG

Sulfadoxine (12.5 mg)/Pyrimethamine (250 mg)

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

Trial Locations (10)

Unknown

RECRUITING

Bandajuma, Bandajuma

RECRUITING

Bandasuma, Bandasuma

RECRUITING

Bendu Malen, Bendu Malen

RECRUITING

Gbondapi, Gbondapi

RECRUITING

Jendema, Jendema

RECRUITING

Potoru, Potoru

RECRUITING

Sahn Malen, Sahn Malen

RECRUITING

Taninahun, Taninahun

RECRUITING

Zimmi, Zimmi

RECRUITING

Static, Pujehun

All Listed Sponsors
collaborator

Project Peanut Butter

OTHER

collaborator

Ministry of Health and Sanitation, Sierra Leone

OTHER_GOV

collaborator

Arla Food Ingredients Group P/S

UNKNOWN

collaborator

The Danish Dairy Research Foundation, Denmark

OTHER

lead

Washington University School of Medicine

OTHER

NCT06869850 - Milk Fat Globule Membrane-Enhanced RUTF for Children With Severe Acute Malnutrition | Biotech Hunter | Biotech Hunter