ORAL DESENSITIZATION TO EGG & INDUCTION OF TOLERANCE FOR EGG ALLERGIC CHILDREN

口腔对鸡蛋脱敏

• 批准号: 7718191
• 负责人: SCOTT H SICHERER
• 金额: $ 2.4万
• 依托单位: ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-03-01 至 2009-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7718191
• 关键词: Allergic; Allergy to eggs; Blinded; Child; Computer Retrieval of Information on Scientific Projects Database; Daily; Dose; Egg Proteins; Egg White; End Point; Funding; Grant; Immunologics; Immunotherapy; Ingestion; Institution; Maintenance; Measures; Oral; Oral Administration; Phase; Placebo Control; Placebos; Prospective Studies; Randomized; Relative (related person); Research; Research Personnel; Resources; Safety; Solid; Source; Time; United States National Institutes of Health; Week; day; desensitization; egg

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is a multi-center randomized, placebo-controlled (and blinded) through 40 weeks, prospective study to investigate the safety and immunologic effects of egg oral immunotherapy for egg allergy. The primary endpoint will be to determine in egg allergic children, whether relative to placebo, daily oral administration of egg white solid escalated over a 10-month period to a maximum of 2000mg/day, increases tolerance as measured by an OFC performed 4-6 weeks after therapy discontinuation by the two year time point. Secondary endpoints include: 1) The percentage of subjects who can tolerate 5 gms of egg white solid after egg OIT following the desensitization phase of the study. 2) The percentage of subjects who tolerate the initial day escalation to 50 mg of egg OIT. 3) The percentage of subjects who achieve the 2 gm maintenance dose of egg OIT during the desensitization phase of the study. Hypothesis: Daily ingestion of small amounts of egg protein will desensitize egg-allergic children (increasing their ability to ingest egg while on therapy) and after long term treatment will induce tolerance to egg (a permanent ability to ingest egg while off therapy).

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这是一项为期40周的多中心随机、安慰剂对照(和盲法)前瞻性研究，旨在调查鸡蛋口服免疫疗法治疗鸡蛋过敏的安全性和免疫学效果。 主要终点将是确定鸡蛋过敏儿童是否相对于安慰剂，在10个月期间每天口服蛋清固体增加到最高2000毫克/天，通过在两年时间点停止治疗4-6周后进行的OFC来衡量是否增加了耐受性。次要终端包括： 1)在研究的脱敏阶段之后，受试者在鸡蛋排出后能耐受5克蛋清固体的百分比。 2)首日耐受率上升至50毫克蛋黄。 3)在研究的脱敏阶段，受试者达到2克鸡蛋油维持量的百分比。 假设：每天摄入少量鸡蛋蛋白会使鸡蛋过敏儿童脱敏(在治疗期间增加他们摄取鸡蛋的能力)，在长期治疗后将诱导对鸡蛋的耐受(一种在停止治疗期间摄取鸡蛋的永久能力)。