Study of Lactoferrin and Lysozyme Supplements to Reduce Diarrhea and Improve Nutrition in Children Aged 6 to 24 Months with Malnutrition

What this Trial Is About

Researchers are studying how nutritional supplements made from milk proteins, lactoferrin and lysozyme, may help children aged 6 to 24 months who were hospitalized for diarrhea and have malnutrition. These children are at high risk of repeated diarrhea and poor nutritional recovery despite receiving usual treatments like oral rehydration solutions. The study is a phase 3, double-blind, placebo-controlled randomized trial taking place at seven hospitals in Western Kenya, enrolling 600 participants. Participants will be randomly assigned to receive one of four treatments daily for 16 weeks lactoferrin, lysozyme, a combination of both, or a placebo made of rice powder. Caregivers will mix the assigned supplement with porridge or other complementary foods. After treatment, children will be followed for a total of 24 weeks with clinic visits at weeks 4, 10, 16, and 24, along with bi-weekly home visits by community health workers. During the study, researchers will collect health history information and samples including stool, blood, and possibly urine. They will monitor diarrhea episodes, nutritional recovery, hospitalizations, growth measurements, and markers of intestinal health. Caregivers will report adherence and acceptability of the supplements. The study aims to assess whether these supplements reduce diarrhea recurrence and improve nutrition over six months, while also evaluating safety and cost-effectiveness.

Lactoferrin and Lysozyme Supplementation for Long-term Diarrhea Sequelae