Milk fat globule membrane–enhanced ready-to-use therapeutic food for children with severe acute malnutrition
MFGM-EnhaNceD RUTF for Children With SAM
This trial will test whether adding milk fat globule membrane (MFGM) to ready-to-use therapeutic food helps children aged 6–59 months with severe acute malnutrition in Sierra Leone improve brain development and reduce death, hospitalization, or persistent malnutrition.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1600 (estimated) |
| Ages | 6 Months to 59 Months |
| Sex | All |
| Sponsor | Washington University School of Medicine Academic / other |
| Locations | 10 sites (Bandajuma, Pujehun and 9 other locations) |
| Trial ID | NCT06869850 on ClinicalTrials.gov |
What this trial studies
Researchers will randomly assign children aged 6–59 months with severe acute malnutrition in participating clinics in Sierra Leone to receive either MFGM-enriched RUTF or standard RUTF, plus routine antibiotics as indicated. Participants will receive two sachets per day for up to 12 weeks, with measurements of weight, length, mid-upper arm circumference, and edema every two weeks during treatment. Neurodevelopmental testing and monitoring for hospitalization, death, and nutritional recovery will be performed to compare outcomes between groups. The trial compares an altered nutrient formulation (MFGM replacing part of skim milk powder) against the current standard RUTF to see if developmental and clinical outcomes improve.
Who should consider this trial
Good fit: Children 6–59 months old who live in the catchment areas of participating clinics, meet SAM criteria (MUAC <11.5 cm, weight-for-length z-score < -3, or bilateral pedal edema), and are well enough for outpatient treatment are ideal candidates.
Not a fit: Children with complicated SAM requiring immediate hospitalization, known allergies to study food ingredients (peanut, milk, fish), recent participation in other feeding programs, or clinically evident developmental delay are excluded and unlikely to benefit from this outpatient intervention.
Why it matters
Potential benefit: If successful, adding MFGM to RUTF could improve neurodevelopmental recovery and reduce death, hospitalization, and persistent severe malnutrition in treated children.
How similar studies have performed: MFGM-enriched foods have shown some benefits for infant neurodevelopment in prior research, but using MFGM specifically in RUTF for children with SAM is a newer application with limited direct evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Features of complicated SAM: inability to tolerate a 30 g test dose of RUTF, breathing difficulties, mental status changes, sepsis, diarrhea with severe dehydration, and/or physician/nursing clinical assessment that the child needs immediate hospitalization * Participation in a separate therapeutic feeding program within the past month * Known allergy to study food ingredient (peanut, milk, fish) * Clinically evident developmental delay (most often determined based on research nursing assessment of physical appearance, movement, and informal discussion with caregiver) * Presence of a chronic severe medical condition (other than tuberculosis and HIV), such as congenital heart disease
Where this trial is running
Bandajuma, Pujehun and 9 other locations
- Bandajuma — Bandajuma, Pujehun, Sierra Leone (Recruiting)
- Bandasuma — Bandasuma, Pujehun, Sierra Leone (Recruiting)
- Bendu Malen — Bendu Malen, Pujehun, Sierra Leone (Recruiting)
- Gbondapi — Gbondapi, Pujehun, Sierra Leone (Recruiting)
- Jendema — Jendema, Pujehun, Sierra Leone (Recruiting)
- Potoru — Potoru, Pujehun, Sierra Leone (Recruiting)
- Sahn Malen — Sahn Malen, Pujehun, Sierra Leone (Recruiting)
- Taninahun — Taninahun, Pujehun, Sierra Leone (Recruiting)
- Zimmi — Zimmi, Pujehun, Sierra Leone (Recruiting)
- Static — Pujehun, Sierra Leone (Recruiting)
Study contacts
- Principal investigator: Mark J Manary, MD — Washington University School of Medicine
- Study coordinator: Mark J Manary, MD
- Email: manarymj@wustl.edu
- Phone: +1 314-454-2341
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.