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Title: Supplementation with lactoferrin and lysozyme ameliorates environmental enteric dysfunction: A double-blind, randomized, placebo-controlled trial

Author
item CHENG, WILLIAM - Washington University
item WOLD, KARI - Washington University
item BOLLINGER, LUCY - Washington University
item ORDIZ, M - Washington University
item SHULMAN, ROBERT - Children'S Nutrition Research Center (CNRC)
item MALETA, KENNETH - University Of Malawi
item MANARY, MARK - Children'S Nutrition Research Center (CNRC)
item TREHAN, INDI - University Of Malawi

Submitted to: American Journal of Gastroenterology
Publication Type: Peer Reviewed Journal
Publication Acceptance Date: 1/16/2019
Publication Date: 2/28/2019
Citation: Cheng, W.D., Wold, K.J., Bollinger, L.B., Ordiz, M.I., Shulman, R.J., Maleta, K.M., Manary, M.J., Trehan, I. 2019. Supplementation with lactoferrin and lysozyme ameliorates environmental enteric dysfunction: A double-blind, randomized, placebo-controlled trial. American Journal of Gastroenterology. 114:671-678. https://doi.org/10.14309/ajg.0000000000000170.
DOI: https://doi.org/10.14309/ajg.0000000000000170

Interpretive Summary: Many of the world's impoverished children suffer from poor growth related to inflammation in the intestine. To date, there have been no effective treatments. This study used two components of breast milk in an attempt to improve growth and reduce intestinal inflammation. Compared to placebo, children who received lactoferrin and lysozyme had less intestinal inflammation, less malnutrition, and fewer hospitalizations. These results are important and require futher testing.

Technical Abstract: 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.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 (Delta%L). Among 214 children who completed the study, there was a significant difference in Delta%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). 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.