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National Jewish Health CoFAR Clinical Research Unit

国家犹太健康 CoFAR 临床研究单位

基本信息

批准号：
10569513
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
项目类别：
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/10569513
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 Goals Health House Dust Hypersensitivity IgE Immune Plasma Individual Infant Infrastructure Linoleic Acids Measures Metagenomics Microbe Milk Nuts Pathogenicity Pediatrics Peripheral Blood Mononuclear Cell Prevention Property RNA Randomized Recommendation Research Research Personnel Risk Role Sampling Skin Skin Care Staphylococcus aureus 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

项目摘要

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.

项目总结/摘要本申请是根据RFA-AI-15-051，食品过敏研究联盟提交的（CoFAR）：临床研究单位（UM 1）。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。我们的中心假设是防止皮肤屏障功能障碍和特应性皮炎（AD）并发金黄色葡萄球菌感染使用亚油酸含有具有抗炎、抗微生物和增强皮肤屏障特性的向日葵籽油，预防早期皮肤过敏原暴露，从而预防两岁时FA的发生。我们将实现我们的目标，目标如下： ·具体目标1：设立一个行政和业务部门，负责在预防和治疗艾滋病毒/艾滋病领域为联合会开展临床试验和研究， FA以及对其潜在机制的理解。临床研究单位还将提供为新的和早期阶段的研究人员提供环境，以发展研究技能，并帮助他们通过他们在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预防皮肤屏障功能障碍、AD和S. 使用含亚油酸的向日葵籽油的金黄色葡萄球菌定殖将减少FA的发生，对高风险与低风险个体进行的前瞻性、随机、对照临床出生队列研究特应性反应主要的临床假设是引入含有亚油酸的向日葵籽油从出生起就可以预防系统性IgE过敏原致敏和通常与AD相关的临床FA (e.g.鸡蛋、牛奶、花生、大豆、小麦、坚果和其他）。 ·具体目标3：确定预防AD和S.使用亚油酸的金黄色葡萄球菌定殖含有向日葵籽油的药物将减少持续性FA和呼吸道过敏的发生，童年.这个次要的临床假设是，引入含有亚油酸的向日葵种子油将减少持续性FA的发生以及对环境过敏的致敏性，已知哮喘与更严重的食物过敏反应和过敏反应有关。本临床出生队列研究将为建立数据和生物样本提供框架储存库（具体目标4），以允许未来研究皮肤屏障功能和致病性的作用与FA相关的机制。