Department of Pediatrics, Washington University, St. Louis, Missouri, USA.
Department of Pediatrics, Case Western Reserve University, Cleveland, Ohio, USA.
Am J Gastroenterol. 2019 Apr;114(4):671-678. doi: 10.14309/ajg.0000000000000170.
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 (Δ%L).
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).
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.
环境肠道功能障碍（EED）使发展中国家的儿童容易受到肠道病原体和发育迟缓的全身性暴露。治疗或预防 EED 的有效干预措施可能有助于儿童充分发挥其身体和认知潜能。本研究的目的是测试母乳中的 2 种成分是否能改善生命第二年 EED 和线性生长的生物标志物。
在马拉维农村地区进行了一项为期 16 周、针对 12-23 个月大儿童的前瞻性、随机、双盲、安慰剂对照临床试验。实验组每天补充 1.5 克乳铁蛋白和 0.2 克溶菌酶。主要结局是通过尿液中摄入的乳果糖排泄百分比的变化（Δ%L）来衡量 EED 的改善。
在 214 名完成研究的儿童中，对照组和实验组在 8 周内的Δ%L 有显著差异（分别增加 0.23%和 0.14%；P=0.04）。然而，在整个 16 周的研究过程中，这种相对改善并没有持续下去（分别增加 0.16%和 0.11%；P=0.17）。在这一短时间内，线性生长没有差异。在研究过程中，实验组的住院率和急性营养不良的发生率明显较低（2.5%比 10.3%，相对风险 0.25；P<0.02）。
在生命的第二年，向农业儿童群体补充乳铁蛋白和溶菌酶对肠道健康有有益的影响。这种干预措施还能预防住院和急性营养不良的发生，这一发现具有重要的临床和公共卫生意义。应该在更大规模、随访时间更长和优化剂量的研究中进一步探讨这一发现。
