Can milk proteins stop deadly diarrhea cycles in malnourished kids?
NCT ID NCT05519254
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 600 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2023
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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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
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6 to 24 months
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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.
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.
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Homa Bay County Referral Hospital
RECRUITINGHoma Bay, Kenya
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Isebania Sub-County Hospital
RECRUITINGIsibania, Kenya
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Kisii Teaching and Referral Hospital
RECRUITINGKisii, Kenya
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Rongo Sub-County Hospital
RECRUITINGRongo, Kenya
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