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）（对不断升级的食物挑战 减少食物过敏的阈值）。 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。研究中许多当前潜在的食物过敏治疗方法针对的是 对非常少量的食物（甚至痕量）产生过敏反应。但是，不是每个人 食物过敏完全过敏。基于对接受诊断进食测试的个人的研究， 大多数经历过敏反应的人在摄取量通常以上的摄入量后会出现症状 茶匙的八分之一，通常更多。目前，当食物过敏的人患有过敏反应时 在诊断进食测试中的反应，他们被指示严格避免食物。这是标准的临床 练习，也是向食物过敏反应的任何人的一般指导。临床护理尚未 到目前为止，建议过敏患者摄入“亚阈值”量的食物过敏原（低于以下的金额 那些引起症状的人）。但是，严格避免可以加快食物过敏的恢复的观念 口服免疫疗法的研究结果完全逆转 过敏原并逐渐增加），以及一种让鸡蛋或牛奶过敏的人的新做法 如果可以的话，面包店的食品（我们的小组在先前的AADCRC赠款中确定的发现 在世界范围内的实践变化中）。这两种方法都表明，如果 耐受性，似乎会增加反应性的阈值，并可能加快恢复的速度。在这里我们使用花生过敏 作为原型。我们的假设是，摄入不断升级的阈值花生数量将是安全的， 增加阈值，并可能加快花生过敏的恢复。这项研究将招募儿童显示 喂养测试期间中等花生过敏，并随机将其避免或摄取小的花生过敏 但是易于测量的食物，低于引起症状的食物。这些孩子会 经过定期监督的喂养测试，以查看是否可以增加金额，并将 遵循当前护理标准的人，避免。此外，研究参与者将具有生物特异性 在该计划中的其他两个项目中获得评估，以了解机制和生物标志物 这可以为花生过敏的个性化方法提供信息。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，也许大多数受影响 个人，并且可以由过敏症患者轻松实施。