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Can milk proteins stop deadly diarrhea cycles in malnourished kids?

NCT ID NCT05519254

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests whether daily supplements of lactoferrin and lysozyme, proteins found in milk, can prevent severe diarrhea and improve nutrition in children aged 6-24 months who were hospitalized with diarrhea and malnutrition. Six hundred children in Kenya will receive one of three supplements or a placebo mixed into their food for 6 months. Researchers will track diarrhea episodes and nutritional recovery to see if these natural proteins help break the cycle of illness and wasting.

What this could mean

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

Active substance
lactoferrin and lysozyme (milk proteins)
What this could lead to
If it works, this could provide a simple, affordable supplement to prevent repeated diarrhea and improve growth in malnourished children.
What could go wrong
This is a large phase 3 trial, but supplements may not work better than standard care. The study only follows children for 6 months, so long-term effects are unknown.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 600 people

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

Started

Mar 2023

Expected to finish

Dec 2026

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 24 months

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Age 6-24 months * Managed as an outpatient or inpatient for diarrhea at one of the recruiting sites * MUAC \<12.5 cm at the time of screening * Plan to stay within the study area for the next 6 months or greater Exclusion Criteria: * Age younger than 6 months or older than 24 months * Caregiver does not provide consent to study participation * History of 2 or more blood transfusions in the past 12 months * Exclusively breastfeeding at the time of enrollment * History of congenital defect or syndrome that prevents age-appropriate feeding (e.g. cleft palate) * History of allergy to dairy products * Child is not ready to return home (is not yet discharged), or discharged against medical advice * Unwilling to participate in the dual sugar permeability sub-study if selected * Enrollment in another study

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Conditions

The condition(s) this trial relates to.

Cachexia Child Nutrition Disorders diarrheal disease nutritional deficiency disease

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    4 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

  • Homa Bay County Referral Hospital

    RECRUITING

    Homa Bay, Kenya

  • Isebania Sub-County Hospital

    RECRUITING

    Isibania, Kenya

  • Kisii Teaching and Referral Hospital

    RECRUITING

    Kisii, Kenya

  • Rongo Sub-County Hospital

    RECRUITING

    Rongo, Kenya

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