Lactoferrin and lysozyme to promote nutritional, clinical, and enteric recovery: A factorial placebo-controlled randomized trial among children with diarrhea and malnutrition.

In this factorial, double-blind, placebo-controlled, randomized trial we aim to determine the efficacy and mechanisms of two breastmilk-derived nutritional supplements, lactoferrin and lysozyme, in minimizing the incidence of diarrhea and promoting nutritional recovery among children recovering from diarrhea and wasting. Kenyan children aged 6-24 months who have been discharged from an inpatient or outpatient hospital stay for diarrhea, and have a mid-upper arm circumference [MUAC] <12.5 cm will be randomized to 16-weeks of lactoferrin, lysozyme, a combination of the two, or placebo. This trial will provide efficacy, mechanistic, and feasibility data from children at risk of poor diarrhea recovery. The Primary collaborators are UW and KEMRI-CCR with funding from NICHD.