Supplementation With Lactoferrin and Lysozyme Ameliorates Environmental Enteric Dysfunction: A Double-Blind, Randomized, Placebo-Controlled Trial.

William D Cheng, Karl J Wold, Lucy B Bollinger, M Isabel Ordiz, Robert J Shulman, Kenneth M Maleta, Mark J Manary, Indi Trehan

Journal: The American journal of gastroenterology 2020;114(4):671-678

PMID: 30829679

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Abstract

INTRODUCTION

Environmental enteric dysfunction (EED) predisposes children throughout the developing world to high rates of systemic exposure to enteric pathogens and stunting. Effective interventions that treat or prevent EED may help children achieve their full physical and cognitive potential. The objective of this study is to test whether 2 components of breast milk would improve a biomarker of EED and linear growth during the second year of life.

METHODS

A prospective, randomized, double-blind, placebo-controlled clinical trial among children aged 12-23 months was conducted in rural Malawi. The experimental group received a daily supplement of 1.5 g of lactoferrin and 0.2 g of lysozyme for 16 weeks. The primary outcome was an improvement in EED, as measured by the change in the percentage of ingested lactulose excreted into the urine (Δ%L).

RESULTS

Among 214 children who completed the study, there was a significant difference in Δ%L between the control and experimental groups over 8 weeks (an increase of 0.23% vs 0.14%, respectively; P = 0.04). However, this relative improvement was not as strongly sustained over the full 16 weeks of the study (an increase of 0.16% vs 0.11%, respectively; P = 0.17). No difference in linear growth over this short period was observed. The experimental intervention group had significantly lower rates of hospitalization and the development of acute malnutrition during the course of the study (2.5% vs 10.3%, relative risk 0.25; P < 0.02).

DISCUSSION

Supplementation with lactoferrin and lysozyme in a population of agrarian children during the second year of life has a beneficial effect on gut health. This intervention also protected against hospitalization and the development of acute malnutrition, a finding with a significant clinical and public health importance. This finding should be pursued in larger studies with longer follow-up and optimized dosing.

Address: Department of Pediatrics, Washington University, St. Louis, Missouri, USA.; Department of Pediatrics, Case Western Reserve University, Cleveland, Ohio, USA.; Department of Pediatrics, Washington University, St. Louis, Missouri, USA.; Department of Pediatrics, Washington University, St. Louis, Missouri, USA.; Department of Pediatrics, University of Washington, Seattle, Washington, USA.; Children's Nutrition Research Center, Baylor College of Medicine, Houston, Texas, USA.; School of Public Health and Family Medicine, University of Malawi, Blantyre, Malawi.; Department of Pediatrics, Washington University, St. Louis, Missouri, USA.; Children's Nutrition Research Center, Baylor College of Medicine, Houston, Texas, USA.; School of Public Health and Family Medicine, University of Malawi, Blantyre, Malawi.; Department of Pediatrics, Washington University, St. Louis, Missouri, USA.; Department of Paediatrics and Child Health, University of Malawi, Blantyre, Malawi.; Lao Friends Hospital for Children, Luang Prabang, Lao PDR.

DOI: 10.14309/ajg.0000000000000170

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MeSH Terms: Child Development, Dietary Supplements, Double-Blind Method, Female, Growth Disorders, Humans, Infant, Infant Nutrition Disorders, Infant Nutritional Physiological Phenomena, Lactoferrin, Malawi, Male, Malnutrition, Muramidase, Prospective Studies, Sprue, Tropical