A prospective registry, biobank and observational study of food allergy

食物过敏的前瞻性登记、生物库和观察研究

• 批准号: 10363634
• 负责人: Corinne Keet
• 金额: $ 250.81万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-03-01 至 2024-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10363634
• 关键词: Adolescent; Affect; Age; Allergic; Allergic Reaction; Allergy to eggs; Allergy to peanuts; American; Asthma; Basophils; Caring; Characteristics; Clinical; Clinical Treatment; Clinical Trials; Complication; Data; Disease; Education; Emergency department visit; Enrollment; Food; Food Hypersensitivity; Frequencies; Fright; Funding; Funding Opportunities; Future; Genetic; Goals; Health Technology; Heterogeneity; Hypersensitivity; IgE; Immunologics; Individual; Infrastructure; Intervention; Investigation; Knowledge; Lead; Leadership; Life; Mediating; Medical; Methods; Milk; Milk Hypersensitivity; Mobile Health Application; Monitor; Observational Study; Patient Recruitments; Patients; Phenotype; Population; Prevention; Reaction; Registries; Research; Resources; Risk; Sampling; Severities; Shapes; base; biobank; clinical biomarkers; clinical care; clinical investigation; clinically relevant; cohort; comorbidity; design; egg; experience; food allergen; innovation; mHealth; method development; novel; personalized medicine; phenotypic biomarker; predictive marker; prospective; reaction rate; recruit; repository; risk benefit ratio; specific biomarkers; treatment response

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.

项目摘要 食物过敏是一种常见疾病，影响多达1500万美国人。虽然在临床上似乎 成为各种各样的疾病，食物过敏的子类型，具有不同的临床课程，合并症和 尚未系统地识别对治疗的反应。确定食物过敏的这种子类型将 允许对食物过敏的人进行量身定制的护理。第二个主要研究差距是我们对 食物过敏的人的绝对风险和严重过敏反应的预测因素 优质的医疗服务。建立严重反应的风险和预测因素将对 确定风险：食物过敏治疗的收益比率，对患者进行教育，确定减少目标 风险，并确定最好的治疗候选人。该建议是创建一个大型存储库，生物库和 通过招募2000名IgE介导的牛奶，鸡蛋的受试者，对食物过敏患者的前瞻性观察性研究 或花生过敏。将使用基于无监督的方法来识别食物过敏的子类型 全面的临床和免疫学数据。对食物的反应速率将使用 创新的移动健康技术。除了这些主要目标外，在此创建的基础设施 通过形成良好表型食品过敏患者的注册表的观察队列 开发监测反应的方法将使Cofar资助的后续临床试验招募 并有效地进行，并将为机会基金提供样本。该项目的具体目的是： （1）建立大型注册表和牛奶，鸡蛋和/或花生过敏的受试者的生物库，（2）建立 食物过敏的表型通过临床和免疫学表征食物过敏的个体（AIM 2A） 并确定这些表型的预测因子（AIM 2B），以及（3）建立食物过敏反应的速率 在食物过敏的个体中（AIM 3A）并确定反应频率和严重程度的预测指标（AIM 3b）。这些调查的结果将有助于通过允许 量身定制食物过敏的人，并通过告知风险：食物过敏治疗的收益比率。这 项目还将通过提供招聘注册表来严重提高食物过敏的研究 科法尔患者，可用于塑造未来临床研究的表型的数据，以及有关 可用于设计新干预措施的反应速率的预测指标。