A prospective registry, biobank and observational study of food allergy

项目摘要 食物过敏是一种常见的疾病，影响着多达1500万美国人。尽管在临床上似乎有 是一种广泛的疾病，具有不同临床病程的食物过敏亚型，共病和 对治疗的反应还没有系统地确定。确定这样的食物过敏亚型将 允许对食物过敏的个体进行量身定制的护理。第二个主要的研究差距是我们对 食物过敏患者中严重过敏反应的绝对风险和预测因素 优质医疗服务。确定严重反应的风险和预测因素将对 确定风险：食物过敏治疗的受益率，教育患者，确定减少 风险，并确定最佳的治疗对象。这项提议是创建一个大型存储库、生物库和 2000例食物过敏患者加入IgE介导的牛奶、鸡蛋的前瞻性观察研究 或者花生过敏。将使用非监督方法识别食物过敏的亚类型，基于 全面的临床和免疫学资料。对食物的反应速度将被密切监测，使用 创新移动健康技术。除了这些主要目标外，在这方面创建的基础设施 通过形成表型良好的食物过敏患者的登记和 监测反应的方法的开发将使由Cofar资助的后续临床试验能够招募 并高效地进行，并将为机会基金提供样本。该项目的具体目标是： (1)建立牛奶、鸡蛋和/或花生过敏受试者的大型登记和生物库；(2)建立 临床和免疫学特征的食物过敏个体的食物过敏表型(目标2A) 并确定这些表型的预测因素(目标2B)，以及(3)建立食物过敏反应的比率 在有食物过敏的个体中(目标3A)，并确定反应频率和严重程度的预测因子(目标3A 3B)。这些调查的结果将有助于为食物过敏患者的临床护理提供信息 为食物过敏患者量身定做的护理，并告知食物过敏治疗的风险：益处比率。这 该项目还将通过提供一个可供招募的注册表来关键地推进对食物过敏的研究 Cofar的患者，可用于塑造未来临床研究的表型数据，以及 反应速率的预测指标，可用于设计新的干预措施。

Project Summary Food allergy is a common disease that affects up to 15 million Americans. Although clinically there appears to be a wide spectrum of disease, sub-types of food allergy with different clinical courses, co-morbidities and responses to therapy have not been systematically identified. Identifying such sub-types of food allergy will allow for tailored care of food allergic individuals. A second major research gap is our understanding of the absolute risk and predictors of serious allergic reactions among those with food allergy who are receiving high quality medical care. Establishing the risk and predictors of serious reactions will have critical implications for determining the risk:benefit ratio for food allergy treatments, educating patients, identifying targets for reducing risk, and determining the best candidates for treatment. This proposal is create a large repository, biobank and prospective observational study of food allergic patients by enrolling 2000 subjects with IgE mediated milk, egg or peanut allergy. Sub-types of food allergy will be identified using unsupervised methods based on comprehensive clinical and immunologic data. The rate of reactions to foods will be closely monitored using innovative mobile health technology. In addition to those major goals, the infrastructure created in this observational cohort through the formation of a registry of well phenotyped food allergic patients and the development of methods to monitor reactions will enable subsequent clinical trials funded by CoFAR to recruit and proceed efficiently, and will provide samples for the opportunity fund. The specific aims of this project are: (1) To establish a large registry and biobank of subjects with milk, egg and/or peanut allergy, (2) To establish phenotypes of food allergy by clinically and immunologically characterizing food allergic individuals (Aim 2A) and to identify predictors of these phenotypes (Aim 2B), and (3) To establish the rate of food allergic reactions among individuals with food allergy (Aim 3A) and determine predictors of reaction frequency and severity (Aim 3B). The results of these investigations will help inform clinical care of food allergic individuals by allowing for tailored care of food allergic individuals, and by informing the risk:benefit ratio for food allergy treatments. This project will also critically advance research into food allergy by providing a registry from which to recruit patients for CoFAR, data on phenotypes which can be used to shape future clinical investigations, and data on predictors of reaction rates which can be used to design novel interventions.