National Jewish Health CoFAR Clinical Research Unit

国家犹太健康 CoFAR 临床研究单位

• 批准号: 10364743
• 负责人: DONALD YM LEUNG
• 金额: $ 23.5万
• 依托单位: NATIONAL JEWISH HEALTH
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-03-02 至 2024-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10364743
• 关键词: 2 year old; Academy; Allergens; Allergic Reaction; American; Anaphylaxis; Anti-Inflammatory Agents; Area; Asthma; Atopic Dermatitis; Biological Specimen Banks; Birth; Cells; Childhood; Clinical; Clinical Protocols; Clinical Research; Clinical Trials; Cohort Studies; DNA; Data; Elements; Environment; Epigenetic Process; Food; Food Analysis; Food Hypersensitivity; Functional disorder; Future; Genus staphylococcus; Goals; Health; House Dust; Hypersensitivity; IgE; Immune Plasma; Individual; Infant; Infection; Infrastructure; Linoleic Acids; Measures; Metagenomics; Microbe; Milk; Nuts; Pathogenicity; Pediatrics; Peripheral Blood Mononuclear Cell; Prevention; Property; RNA; Randomized; Research; Research Personnel; Risk; Role; Sampling; Skin; Skin Care; Staphylococcus aureus infection; Sunflower Oil; Swab; Technology; Trees; Water; Wheat; Work; antimicrobial; atopy; clinical trial implementation; cohort; egg; environmental allergy; follower of religion Jewish; food allergen; high risk; metatranscriptomics; microbiome research; operation; preservation; prevent; prospective; respiratory; response; skills; skin barrier; soy; standard of care; transcriptomics

Project Summary/Abstract This application is being submitted in response to RFA-AI-15-051, Consortium for Food Allergy Research (CoFAR): Clinical Research Units (UM1). The goal of this proposal is to establish an infrastructure and clinical strategies to prevent and manage food allergy (FA). Our central hypothesis is that prevention of skin barrier dysfunction and atopic dermatitis (AD) complicated by Staphylococcus aureus infection using a linoleic acid containing sunflower seed oil with anti-inflammatory, anti-microbial, and skin barrier enhancing properties will prevent early skin allergen exposure and thereby prevent the occurrence of FA at two years of age. We will achieve our objectives with the following aims: · Specific Aim 1: To establish an Administration and Operations Element that will be responsible for implementation of clinical trials and studies for the Consortium in the areas of prevention and treatment of FA as well as an understanding of its underlying mechanisms. The Clinical Research Unit will also provide an environment for New and Early Stage Investigators to develop research skills and assist them in progressing to more senior status through their work in CoFAR. · Specific Aim 2: To perform a Clinical Trial to determine if prevention of skin barrier dysfunction, AD and S. aureus colonization using linoleic acid containing sunflower seed oil will reduce the occurrence of FA in a prospective, randomized, controlled clinical Birth Cohort study of individuals at high risk vs. low risk of atopy. The primary clinical hypothesis is that introduction of a linoleic acid containing sunflower seed oil from birth will prevent systemic IgE allergen sensitization and clinical FA commonly associated with AD (e.g. egg, milk, peanut, soy, wheat, tree nuts and others). · Specific Aim 3: To determine if prevention of AD and S. aureus colonization using a linoleic acid containing sunflower seed oil will reduce the occurrence of persistent FA and respiratory allergy later in childhood. This secondary clinical hypothesis is that introduction of a linoleic acid containing sunflower seed oil will reduce the occurrence of persistent FA as well as sensitization to environmental allergies and asthma which is known to be associated with more severe food allergic reactions and anaphylaxis. This clinical Birth Cohort Study will provide a framework for establishment of a data and biological specimen repository (specific aim 4) to allow future studies of the role of skin barrier function and pathogenic mechanisms related to FA.

项目概要/摘要 本申请是为了响应食物过敏研究联盟 RFA-AI-15-051 的要求而提交的 (CoFAR)：临床研究单位 (UM1)。该提案的目标是建立基础设施和临床 预防和管理食物过敏（FA）的策略。我们的中心假设是预防皮肤屏障 使用亚油酸治疗金黄色葡萄球菌感染并发的功能障碍和特应性皮炎 (AD) 含有具有抗炎、抗菌和增强皮肤屏障特性的葵花籽油 预防早期皮肤过敏原暴露，从而预防两岁时发生 FA。我们将 通过以下目标实现我们的目标： · 具体目标 1：建立一个管理和运营部门，负责 为联盟在预防和治疗领域开展临床试验和研究 FA 以及对其底层机制的理解。临床研究单位还将提供 为新的和早期研究人员提供一个发展研究技能并协助他们的环境 通过在 CoFAR 的工作晋升到更高的职位。 · 具体目标 2：进行临床试验以确定是否可以预防皮肤屏障功能障碍、AD 和 S。 使用含有葵花籽油的亚油酸定植金黄色葡萄球菌会减少 FA 的发生 对高风险个体与低风险个体进行前瞻性、随机、对照临床出生队列研究 特应性。主要的临床假设是引入含有葵花籽油的亚油酸 从出生起就可以预防全身性 IgE 过敏原致敏和通常与 AD 相关的临床 FA （例如鸡蛋、牛奶、花生、大豆、小麦、坚果等）。 · 具体目标 3：确定使用亚油酸是否可以预防 AD 和金黄色葡萄球菌定植 含有葵花籽油会减少后期持续性FA和呼吸道过敏的发生 童年。这个次要的临床假设是引入含有向日葵的亚油酸 种子油将减少持久性 FA 的发生以及对环境过敏的敏感性， 众所周知，哮喘与更严重的食物过敏反应和过敏反应有关。 这项临床出生队列研究将为建立数据和生物样本提供一个框架 存储库（具体目标 4）允许未来研究皮肤屏障功能和致病性的作用 FA 相关机制。