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/抽象自助餐厅试验(项目1)(升级对食品的挑战 降低食物过敏的阈值)。 食物过敏影响多达8%的儿童和大约5%的成年人，对 生活质量和营养。目前正在研究的许多潜在的食物过敏治疗针对的是那些 对极少量的食物甚至微量的食物都会产生过敏反应。然而，并不是每个人都有 食物过敏是一种极其敏感的疾病。基于对接受诊断喂养测试的个体的研究， 大多数发生过敏反应的人在摄入的量通常超过 八分之一茶匙，通常更多。目前，当对食物过敏的人对 在诊断性喂养试验中的反应，他们被指示严格避免进食；这是标准的临床 也是对报告食物过敏反应的人的一般指导。临床护理还没有 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 那些引起症状的人)。然而，严格避免食物过敏可能会加速食物过敏的恢复 完全被口服免疫疗法的研究结果逆转(最初给予微量的 过敏原和逐渐增加)和一种新的做法，让鸡蛋或牛奶过敏的人摄入这些 烘焙食品中的食物，如果它们可能的话(这是我们小组在AADCRC之前的一项拨款中发现的，结果是 在世界范围内的实践变化中)。这两种方法都表明，如果摄入过敏原， 耐受性，似乎提高了反应性阈值，并可能加速恢复。在这里我们用花生过敏 作为一个原型。我们的假设是，摄入不断增加的低于临界量的花生是安全的， 提高阈值，可能会加速花生过敏的恢复。这项研究将招募被证明患有 在喂养试验期间对花生中度过敏，并随机选择继续回避或摄入少量花生。 但食物的量很容易测量，低于引起症状的量。这些孩子会 接受定期的监督喂养测试，看看是否可以增加数量，并将与 那些遵循目前的谨慎标准的人，避免。此外，研究参与者将拥有生物标本 在该计划的另外两个项目中获得评估，以了解机制和生物标记物 这可以提供一种个性化的花生过敏方法。如果这种方法成功，它将从根本上 改变全球花生过敏管理的方法，可能对大多数受影响的人来说 过敏症专科医生可以很容易地实施。