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: 10322136
• 负责人: Patricia Pavlinac
• 金额: $ 55.39万
• 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/10322136
• 关键词: 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 health status; Functional disorder; Future; Growth; Health; Health care facility; Health system; Hemoglobin; Home; Hospitalization; 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; Rehydrations; Reporting; Rhamnose; Risk; Safety; Shigella; Supplementation; Testing; Therapeutic Intervention; Time; Translating; 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; 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; randomized 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.

项目摘要/摘要 腹泻每年杀死超过半百万的儿童，是残疾失败的第三大贡献者 调整了生活年。虽然补液解决腹泻的急性后果，但没有干预措施 对于腹泻的恢复，儿童处于营养不良的高风险，低呼吸道 感染和反复出现的腹泻发作。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牛奶来源的营养补充剂，可减少腹泻的持续时间 发作，治疗或预防潜在的肠道感染，改善肠功能并加速营养 恢复。但是，尚不清楚其抗菌作用是否会转化为重要 儿童腹泻的长期临床和营养结局的改善。我们提出了一个阶乘， 双盲，安慰剂对照，随机试验，以确定乳铁蛋白和机制 补充溶菌酶，以最大程度地减少腹泻的发生率并促进营养恢复 儿童从腹泻和浪费中恢复过来。肯尼亚儿童已出院6-24个月 从住院或门诊医院住宿腹泻，并有一个中等臂围[MUAC] <12.5 CM将随机分为16周的乳铁蛋白，溶菌酶，两者或安慰剂的组合。这个审判将 提供最有可能受益于这些人口的大量功效，机械和可行性数据 干预措施。