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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.

项目摘要/摘要本申请是根据食物过敏研究联盟RFA-AI-15-051的要求提交的 (COFAR)：临床研究单位(UM1)。这项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)的战略。我们的中心假设是预防皮肤屏障亚油酸治疗功能障碍和特应性皮炎(AD)合并金黄色葡萄球菌感染含有葵花籽油，具有消炎、抗微生物和增强皮肤屏障的特性防止早期皮肤过敏原暴露，从而防止两岁时FA的发生。我们会实现我们的目标，实现以下目标： ·具体目标1：设立一个行政和业务部门，负责该联盟在预防和治疗疟疾方面的临床试验和研究的实施情况以及对其潜在机制的理解。临床研究股还将提供为新的和早期的研究人员发展研究技能和协助他们提供环境通过在中粮集团的工作提升到更高的地位。 ·具体目标2：进行一项临床试验，以确定预防皮肤屏障功能障碍、AD和S。使用含有亚油酸的葵花籽油定植金黄色葡萄球菌将减少FA在高危人群与低危人群的前瞻性、随机、对照临床出生队列研究过敏症。主要的临床假设是引入一种含有葵花籽油的亚油酸从出生起就将预防系统性IgE过敏原敏化和临床FA通常与AD相关 (例如鸡蛋、牛奶、花生、大豆、小麦、坚果等)。 ·具体目标3：确定是否使用亚油酸预防AD和金黄色葡萄球菌的定植含有葵花籽油将减少持续性FA和呼吸道过敏的发生童年。这个次要的临床假设是引入一种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和哮喘，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样本提供一个框架资料库(特定目标4)，以便将来研究皮肤屏障功能和致病因素的作用与FA相关的机制。