Lactoferrin and Lysozyme Supplementation for Long-term Diarrhea Sequelae

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Diarrhea, Wasting, Malnutrition, Child

In brief

Children in low- and middle-income countries who are hospitalized for diarrhea and also have malnutrition are at high risk for illness and death in the 6 months period following treatment for diarrhoea despite receiving current guideline recommended diarrhea management (such as oral rehydration solution, or "ORS"). This study will test whether nutritional supplements made from milk (lactoferrin or lysozyme) or a combination of the two (lactoferrin and lysozyme) will prevent children from having repeated diarrhea episodes and help improve their nutrition by improving their stomach health or preventing new disease during this 6-month period. The study is taking place at 7 hospitals in Western Kenya. Six hundred participants will be enrolled if they provide informed consent to participate, are aged 6-24 months, were hospitalized with diarrhea and malnutrition and have been managed by the facility nutritionists and ready to return home. Participation in the study will entail providing information on the child's health history, collection of stool samples, blood, and potentially urine. The caregiver will be provided sachets of the investigational product to take home and mix daily with their child's porridge or other complimentary food, and asked to return to the clinic 4 times in the subsequent 6 months, and also consent to having a community health worker visit their home every two weeks for a follow up visit. The risks to the participant and their caregiver are minimal. The information gained in this study will help us create new treatments and develop new strategies to treat sick children to prevent death and illness.

Key facts

Study ID

NCT05519254

Run by

University of Washington

People needed

600

Starts

2023-03-10

Expected to finish

2026-12-01

Last updated by the study team

2025-09-11

Who can join

Age: 1 and older, up to 2. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Homa Bay County Referral Hospital — Homa Bay, Kenya (enrolling)
• Isebania Sub-County Hospital — Isibania, Kenya (enrolling)
• Kisii Teaching and Referral Hospital — Kisii, Kenya (enrolling)
• Rongo Sub-County Hospital — Rongo, Kenya (enrolling)

Full record on ClinicalTrials.gov

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