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

> **NIH NIH R01** · UNIVERSITY OF WASHINGTON · 2022 · $553,912

## Abstract

PROJECT SUMMARY/ABSTRACT
 Diarrhea kills more than half a million children each year and is the third largest contributor to lost disability
adjusted life years. While rehydration addresses the acute consequences of diarrhea, there are no interventions
for diarrhea convalescence during which children are at high risk of malnutrition, lower-respiratory tract
infections, and recurring diarrhea episodes. Safe and effective interventions to address the long-term
consequences of diarrheal disease are urgently needed.
Lactoferrin and lysozyme are milk-derived nutritional supplements that may reduce the duration of diarrheal
episodes, treat or prevent underlying enteric infections, improve enteric function, and accelerate nutritional
recovery. However, it remains unclear whether their antimicrobial action will translate into significant
improvements in the long-term clinical and nutritional outcomes of childhood diarrhea. We propose a factorial,
double-blind, placebo-controlled, randomized trial to determine the efficacy and mechanisms of lactoferrin and
lysozyme supplementation 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 much efficacy, mechanistic, and feasibility data from populations most likely to benefit from these
interventions.

## Key facts

- **NIH application ID:** 10322136
- **Project number:** 5R01HD103642-02
- **Recipient organization:** UNIVERSITY OF WASHINGTON
- **Principal Investigator:** Patricia Pavlinac
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $553,912
- **Award type:** 5
- **Project period:** 2021-01-01 → 2025-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10322136

## Citation

> US National Institutes of Health, RePORTER application 10322136, Lactoferrin and lysozyme to promote nutritional, clinical, and enteric recovery: A factorial placebo-controlled randomized trial among children with diarrhea and malnutrition (5R01HD103642-02). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10322136. Licensed CC0.

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