Lactoferrin and Lysozyme Supplementation for Long-term Diarrhea Sequelae

Launched by UNIVERSITY OF WASHINGTON · Aug 24, 2022

Keywords

ClinConnect Summary

This clinical trial is studying whether nutritional supplements made from milk, specifically lactoferrin and lysozyme, can help children who have had diarrhea and are also malnourished. The goal is to see if these supplements can prevent further episodes of diarrhea and improve the children's nutrition over the next six months. The study is taking place in seven hospitals in Western Kenya and aims to enroll 600 children aged 6 to 24 months who were hospitalized for diarrhea and are ready to go home.

If your child is eligible and you decide to participate, you will need to provide some health information and allow for collection of stool, blood, and possibly urine samples. You will receive sachets of the supplements to mix with your child’s food daily. Over the next six months, you will visit the clinic four times, and a community health worker will come to check on your child every two weeks. The risks of participating are minimal, and the findings from this study could lead to better treatments for children suffering from diarrhea in the future.

Gender

ALL

Eligibility criteria

• 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