TY - JOUR
T1 - Supplementation with Lactoferrin and Lysozyme Ameliorates Environmental Enteric Dysfunction
T2 - A Double-Blind, Randomized, Placebo-Controlled Trial
AU - Cheng, William D.
AU - Wold, Karl J.
AU - Bollinger, Lucy B.
AU - Ordiz, M. Isabel
AU - Shulman, Robert J.
AU - Maleta, Kenneth M.
AU - Manary, Mark J.
AU - Trehan, Indi
N1 - Funding Information:
Financial support: Funding was provided by the Children's Discovery Institute of Washington University and St. Louis Children's Hospital and the United States Department of Agriculture (CRIS 6250-51000-057-025). The sponsor had no role in any aspect of the study design, data collection, analysis, interpretation of data, or manuscript preparation.
Funding Information:
Financial support: Funding was provided by the Children’s Discovery Institute of Washington University and St. Louis Children’s Hospital and the United States Department of Agriculture (CRIS 6250-51000-057-025). The sponsor had no role in any aspect of the study design, data collection, analysis, interpretation of data, or manuscript preparation. Potential competing interests: None.
Publisher Copyright:
© 2019 by The American College of Gastroenterology.
PY - 2019/4/1
Y1 - 2019/4/1
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85064326396&partnerID=8YFLogxK
U2 - 10.14309/ajg.0000000000000170
DO - 10.14309/ajg.0000000000000170
M3 - Article
C2 - 30829679
AN - SCOPUS:85064326396
SN - 0002-9270
VL - 114
SP - 671
EP - 678
JO - The American Journal of Gastroenterology
JF - The American Journal of Gastroenterology
IS - 4
ER -