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

乳铁蛋白和溶菌酶促进营养、临床和肠道恢复：针对腹泻和营养不良儿童的阶乘安慰剂对照随机试验

• 批准号: 10533817
• 负责人: Patricia Pavlinac
• 金额: $ 55.19万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-01-01 至 2025-11-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10533817
• 关键词: Acceleration; Acute; Address; Adherence; Anemia; Antibiotic Resistance; Antibiotics; Area; Campylobacter; Caregivers; Cessation of life; Child; Childhood; Chinese; Clinical; Cold Chains; Combined Modality Therapy; Convalescence; Data; Dehydration; Deterioration; Diarrhea; Double-Blind Method; Enteral; Enterobacteriaceae; Failure; Family; Functional disorder; Future; Growth; Health; Health care facility; Health system; Hemoglobin; Home; Hospitalization; Hydration status; Incidence; Infection; Inpatients; Intervention; Intestines; Iron; Kenya; Lactoferrin; Lactulose; Length of Stay; Lower Respiratory Tract Infection; Malaria; Malnutrition; Medical; Micronutrients; Milk; Muramidase; Neopterin; Nutritional; ORALIT; Outcome; Outpatients; Participant; Peroxidases; Peru; Peruvian; Placebo Control; Placebos; Population; Prevalence; Randomized; Randomized, Controlled Trials; Recovery; Recurrence; Reporting; Rhamnose; Risk; Risk Reduction; Safety; Shigella; Supplementation; Testing; Therapeutic Intervention; Time; Translating; Trypsin; Upper arm; Visit; Zinc; adverse outcome; aged; antimicrobial; cognitive development; cost; cost effective intervention; cost effectiveness; diarrheal disease; dietary supplements; disability-adjusted life years; effective intervention; efficacy evaluation; enteric infection; enteric pathogen; enteroaggregative Escherichia coli; experience; high risk; improved; improved outcome; low and middle-income countries; medical attention; micronutrient deficiency; mortality risk; novel; prevent; randomized placebo controlled trial; standard of care; wasting

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.

项目总结/摘要 腹泻每年导致50多万儿童死亡，是造成残疾的第三大因素 调整生命年虽然补液可以解决腹泻的急性后果，但没有干预措施 对于腹泻恢复期，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。采取安全有效的干预措施， 因此，迫切需要消除疟疾的后果。 乳铁蛋白和溶菌酶是乳源性营养补充剂，可能会减少腹泻的持续时间 发作，治疗或预防潜在的肠道感染，改善肠道功能，并加速营养 复苏然而，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。我们提出一个阶乘， 一项双盲、安慰剂对照、随机试验，旨在确定乳铁蛋白和 补充溶菌酶在减少腹泻发生率和促进营养恢复方面的作用 正在从腹泻和消瘦中恢复的儿童。已出院的6-24个月的肯尼亚儿童 因腹泻住院或门诊，上臂中围[MUAC] <12.5 CM将被随机分配至16周的乳铁蛋白、溶菌酶、两者的组合或安慰剂。本试验将 从最有可能从中受益的人群中提供了大量的疗效、机制和可行性数据， 干预措施。