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.

项目摘要/摘要该申请正在响应RFA-AI-15-051，食品过敏研究联盟（Cofar）：临床研究单位（UM1）。该建议的目的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葡萄球菌感染的功能障碍和特应性皮炎（AD）复杂含有抗炎，抗微生物和皮肤屏障的增强特性的葵花籽油将防止早期皮肤过敏原暴露，从而防止FA在两岁时发生。我们将实现我们的目标以以下目的： ·特定目的1：建立将负责的管理和运营要素在预防和治疗领域实施财团的临床试验和研究 FA以及对其潜在机制的理解。临床研究部门还将提供新的和早期调查人员发展研究技能并协助他们的环境通过他们在科法尔的工作发展更高的高级地位。 ·具体目的2：进行临床试验以确定防止皮肤屏障功能障碍，AD和S。使用含有葵花籽油的亚油酸定植的金黄色葡萄糖定殖将减少FA在A中的发生前瞻性，随机，受控的临床出生队列研究高风险与低风险 atopy。主要的临床假设是引入含有葵花籽油的亚油酸从出生起将防止全身性IgE过敏原传感化和临床FA通常与AD相关（例如，鸡蛋，牛奶，花生，大豆，小麦，树坚果等）。特定目的3：确定使用亚油酸预防AD和金黄色葡萄球菌定植含有葵花籽油将减少持续的FA的发生童年。次要临床假设是引入含日葵花的亚油酸种子油将减少持续的FA的发生以及对环境过敏和的敏感性哮喘已知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标本提供一个框架存储库（特定目的4）以将来研究皮肤屏障功能和致病性的作用与FA有关的机制。