What is this trial studying for children with severe acute malnutrition?

This trial is studying whether adding milk fat globule membrane (MFGM) to ready-to-use therapeutic food (RUTF) can improve brain development and reduce serious health problems in young children with severe acute malnutrition in Sierra Leone. The research is sponsored by Washington University School of Medicine and aims to help children recover better both physically and cognitively.

Who may be eligible for this severe acute malnutrition clinical trial?

Children aged 6 to 59 months who live in the area of a participating clinic and have severe acute malnutrition based on specific measurements may be eligible. Children must not have serious complications, allergies to study foods, or recent participation in other feeding programs. Please review eligibility criteria for more details.

Is there any cost to participate in this severe acute malnutrition clinical trial?

Study-related care, including the study food and all trial visits, is provided at no cost. However, personal travel expenses to attend the clinic visits may vary and are not guaranteed to be covered by the study.

Actively Recruiting

Phase Not Applicable

Age: 6Months - 59Months

All Genders

ID06869850

Testing Milk Fat Globule Membrane in Ready-to-Use Therapeutic Food for Children 6-59 Months with Severe Acute Malnutrition in Sierra Leone to Improve Brain Development and Survival

Led by Washington University School of Medicine · Updated on 2025-12-17

1600

Participants Needed

Research Sites

N/A

Total Duration

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

Age: 6Months - 59Months

All Genders

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

Research Team

Mark J Manary, MD

Kevin B Stephenson, MD

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