ORAL DESENSITIZATION TO EGG AND SUBSEQUENT INDUCTION OF TOLERANCE

口腔对鸡蛋脱敏并随后诱导耐受

• 批准号: 7953701
• 负责人: SCOTT H SICHERER
• 金额: $ 8.22万
• 依托单位: ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-03-01 至 2009-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7953701
• 关键词: Allergic; Allergy to eggs; Blinded; Child; Clinical Research; Computer Retrieval of Information on Scientific Projects Database; Dose; Egg Proteins; Egg White; 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; 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的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 这是一项为期40周的多中心随机、安慰剂对照（盲法）前瞻性研究，旨在研究鸡蛋口服免疫疗法对鸡蛋过敏的安全性和免疫学影响。 主要终点将是确定在鸡蛋过敏儿童中，相对于安慰剂，每天口服白色固体在10个月期间递增至最大2000 mg/天，是否增加了耐受性，如通过在治疗停止后4-6周至2年时间点进行的OFC所测量的。 次要终点包括： 第一章 在研究脱敏阶段后，鸡蛋OIT后能够耐受5 g白色固体的受试者百分比。 （二） 耐受初始日递增至50 mg鸡蛋OIT的受试者百分比。 第三章 在研究脱敏阶段达到2 gm鸡蛋OIT维持剂量的受试者百分比。 假设：每天摄入少量的鸡蛋蛋白将使鸡蛋过敏的儿童脱敏（增加他们在治疗期间摄入鸡蛋的能力），并在长期治疗后诱导对鸡蛋的耐受性（在停止治疗时摄入鸡蛋的永久能力）。