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Could a milk ingredient boost brain health in starving kids?

NCT ID NCT06869850

Disease control Sponsor: Washington University School of Medicine Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether adding milk fat globule membrane (MFGM) to a standard therapeutic food helps brain development and reduces death or hospitalization in 1,600 severely malnourished children aged 6-59 months in Sierra Leone. Children receive either the MFGM-enriched food or standard food for up to 12 weeks, with follow-up assessments. The goal is to improve outcomes for a devastating condition.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
MFGM-enriched ready-to-use therapeutic food (MFGM-RUTF)
What this could lead to
If it works, this could improve brain development and reduce deaths in children with severe acute malnutrition.
What could go wrong
This is a large but early-stage trial; the added ingredient may not show significant benefit over standard treatment, and results may not apply to other populations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 1,600 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 to 59 months

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Cachexia Cognitive Dysfunction kwashiorkor nutritional deficiency disease protein-energy malnutrition Severe Acute Malnutrition

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cognitive impairment Kwashiorkor Severe acute malnutrition Severe wasting

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    10 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Bandajuma

    RECRUITING

    Bandajuma, Pujehun, Sierra Leone

  • Bandasuma

    RECRUITING

    Bandasuma, Pujehun, Sierra Leone

  • Bendu Malen

    RECRUITING

    Bendu Malen, Pujehun, Sierra Leone

  • Gbondapi

    RECRUITING

    Gbondapi, Pujehun, Sierra Leone

  • Jendema

    RECRUITING

    Jendema, Pujehun, Sierra Leone

  • Potoru

    RECRUITING

    Potoru, Pujehun, Sierra Leone

  • Sahn Malen

    RECRUITING

    Sahn Malen, Pujehun, Sierra Leone

  • Static

    RECRUITING

    Pujehun, Sierra Leone

  • Taninahun

    RECRUITING

    Taninahun, Pujehun, Sierra Leone

  • Zimmi

    RECRUITING

    Zimmi, Pujehun, Sierra Leone

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