ChAllenging to Foods with Escalating ThrEsholds for ReducIng Food Allergy

挑战食品，提高减少食物过敏的阈值

• 批准号: 10415891
• 负责人: SCOTT H SICHERER
• 金额: $ 40.71万
• 依托单位: ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-06-06 至 2023-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10415891
• 关键词: Address; Adult; Affect; Allergens; Allergic; Allergic Reaction; Allergy to eggs; Allergy to peanuts; Biological Markers; Biological Products; Child; Clinical; Combined Modality Therapy; Diagnostic; Dose; Eating; Enrollment; Evaluation; Food; Food Hypersensitivity; Foundations; Goals; Grant; Home; Hypersensitivity; Immune; Immunologics; Immunotherapeutic agent; Immunotherapy; Individual; Ingestion; Instruction; Intervention; Measurable; Medical; Milk; Milk Hypersensitivity; Nutritional; Oral; Participant; Patients; Periodicity; Persons; Phenotype; Production; Proteins; Protocols documentation; Quality of life; Randomized; Reaction; Recovery; Reporting; Safety; Sampling; Schedule; Severities; Specimen; Speed; Supervision; Sustainable Development; Symptoms; Target Populations; Testing; Visit; allergic response; base; clinical care; clinical practice; cost; desensitization; dietary approach; egg; experience; feeding; food allergen; food challenge; intervention cost; neglect; nutrition; omalizumab; oral diagnostics; oral immunotherapy; personalized approach; programs; prototype; reaction rate; response; side effect; standard of care; success

Project Summary/Abstract CAFETERIA Trial (Project 1) (ChAllenging to Foods with Escalating ThrEsholds for ReducIng Food Allergy). Food allergy affects up to 8% of children and approximately 5% of the adults, with serious consequences for quality of life and nutrition. Many current potential food allergy treatments under study address individuals who develop allergic reactions to very small amounts of the food, even trace amounts. However, not everyone with food allergy is exquisitely allergic. Based on studies of individuals undergoing diagnostic feeding tests, the majority experiencing allergic reactions develop symptoms after having ingested amounts that are often above an eighth of a teaspoon and usually much more. Currently, when a person with food allergy has an allergic reaction during a diagnostic feeding test, they are instructed to strictly avoid the food; this is standard clinical practice and is also a general instruction for anyone reporting allergic reactions to a food. Clinical care has not suggested, thus far, that allergic patients ingest “sub-threshold” amounts of food allergen (amounts below those causing symptoms). However, the notion that strict avoidance could speed recovery of a food allergy has been entirely reversed by the results of studies of oral immunotherapy (giving initially trace amounts of an allergen and gradually increasing) and a new practice of having persons with egg or milk allergy ingest these foods in bakery goods if they are able (a finding identified by our group in a prior AADCRC grant that resulted in a worldwide change in practice). Both of these approaches have shown that ingestion of the allergen, if tolerated, appears to increase the threshold of reactivity and may speed recovery. Here we use peanut allergy as a prototype. Our hypothesis is that ingesting escalating sub-threshold amounts of peanut will be safe, increase threshold, and may speed recovery of peanut allergy. The study will enroll children shown to have moderate peanut allergy during a feeding test and randomize them to continue avoidance or to ingest a small but easily measurable amount of the food, an amount below that which causes symptoms. These children will undergo periodic supervised feeding tests to see if the amount can be increased, and will be compared to those following the current standard of care, avoidance. In addition, study participants will have bio-specimens obtained for evaluation in two additional Projects in this Program to understand mechanisms and biomarkers that can inform a personalized approach to peanut allergy. If this approach is successful, it will fundamentally change the worldwide approach to peanut allergy management, for perhaps the majority of affected individuals, and can be implemented easily by allergists.

项目摘要/摘要自助餐厅试验（项目 1）（对食品提出挑战，逐步升级） 减少食物过敏的阈值）。 食物过敏影响高达 8% 的儿童和约 5% 的成人，对身体造成严重后果 目前正在研究的许多潜在的食物过敏治疗针对的是以下人群： 对极少量的食物，甚至微量的食物，都会产生过敏反应，但并不是每个人都会出现过敏反应。 根据对接受诊断性喂养测试的个体的研究，食物过敏是一种严重过敏。 大多数经历过敏反应的人在摄入量通常高于 目前，当患有食物过敏的人出现过敏时，通常需要八分之一茶匙。 在诊断性喂养测试期间出现反应，他们被指示严格避免进食，这是标准的临床表现； 实践，也是对任何报告食物过敏反应的人的一般指导。 到目前为止，建议过敏患者摄入“低于​​阈值”量的食物过敏原（低于阈值的量） 然而，严格避免食物过敏可以加速恢复的观念已经出现。 口服免疫疗法的研究结果完全逆转了这种情况（最初给予微量的 过敏原并逐渐增加）以及让鸡蛋或牛奶过敏的人摄入这些的新做法 烘焙食品中的食品（如果有能力的话）（我们小组在之前的 AADCRC 拨款中发现的一项发现，导致 这两种方法都表明，如果摄入过敏原，则可能会导致过敏原的发生。 耐受性，似乎会增加反应阈值并可能加速恢复，在这里我们使用花生过敏。 作为原型，我们的假设是摄入低于阈值的花生是安全的， 提高阈值，并可能加速花生过敏的恢复 该研究将招募患有花生过敏的儿童。 在喂养测试中对花生过敏，然后将他们随机分组以继续避免或摄入少量花生 但容易测量的食物量，低于引起这些孩子症状的量。 定期进行监督喂养测试，看看是否可以增加数量，并将与 此外，研究参与者还将获得生物样本。 获得用于本计划中另外两个项目的评估，以了解机制和生物标志物 如果这种方法成功，它将从根本上指导花生过敏的个性化治疗。 改变全球花生过敏管理方法，也许对大多数受影响的人来说 个人，并且可由过敏症专科医生轻松实施。