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

项目摘要/摘要 腹泻每年导致50多万儿童死亡，是导致残疾的第三大因素 调整后的寿命年。虽然补液可以解决腹泻的严重后果，但没有干预措施。 用于腹泻的恢复期，在此期间儿童营养不良的风险很高，下呼吸道 感染和反复腹泻发作。安全有效的干预措施，以解决长期 迫切需要腹泻病的后果。 乳铁蛋白和溶菌酶是从牛奶中提取的营养补充剂，可以缩短腹泻持续时间。 治疗或预防潜在的肠道感染，改善肠道功能，加速营养 恢复。然而，目前尚不清楚它们的抗菌作用是否会转化为显著的 改善儿童腹泻的长期临床和营养结果。我们提出了一个阶乘， 双盲、安慰剂对照、随机试验以确定乳铁蛋白和乳铁蛋白的疗效和作用机制 补充溶菌酶降低婴幼儿腹泻发生率及促进营养恢复的研究 从腹泻和消瘦中恢复的儿童。已出院的6-24个月大的肯尼亚儿童 住院病人或门诊病人因腹泻而住院，并有中上臂围[MUAC]&lt；12.5 CM将随机接受乳铁蛋白、溶菌酶、两者的组合或安慰剂治疗16周。这场审判将 从最有可能从中受益的人群中提供更多的有效性、机械性和可行性数据 干预措施。

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.