Isibania

Researchers are evaluating whether nutritional supplements made from milk proteins lactoferrin and lysozyme, alone or combined, can reduce repeated diarrhea episodes and improve nutritional recovery in children aged 6 to 24 months hospitalized with diarrhea and malnutrition in Western Kenya. This Phase 3 randomized, double-blind, placebo-controlled trial aims to address the high risk of illness and death faced by these children despite current diarrhea treatments like oral rehydration solution. The study will enroll 600 children with moderate or severe wasting (MUAC <12.5 cm) to test if these supplements can improve gut health and prevent new disease during a 6-month follow-up period. Participants will be randomly assigned to receive either lactoferrin, lysozyme, a combination of both, or a placebo for 16 weeks. Caregivers will be instructed to mix the supplements daily with their child's porridge or other complementary foods. The study includes bi-weekly home visits by community health workers and clinic visits at 4, 10, 16, and 24 weeks. This design allows monitoring of the supplements' effects and adherence over 6 months. Throughout the study, information on the child's health history will be collected along with stool, blood, and possibly urine samples to evaluate enteric infections, enteric function, and hemoglobin levels. The main outcomes measured are the incidence of moderate-to-severe diarrhea and the time to nutritional recovery over 6 months. Safety and acceptability will be assessed, and caregivers' adherence to the supplements will be monitored. The results aim to inform new strategies to reduce mortality and complications in malnourished children recovering from diarrhea.