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).

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 这是一项多中心的随机，安慰剂对照（且盲目）40周的前瞻性研究，以研究卵口服免疫疗法对卵过敏的安全性和免疫学作用。 主要终点是确定卵过敏的儿童，无论是相对于安慰剂，每天口服蛋清固体在10个月内升级至最大2000毫克/天，这都会提高耐受性，这是通过两年时间终止治疗后4-6周进行的OFC测量的。 次要端点包括： 1）在研究的脱敏阶段，在卵OIT之后耐受5克白色固体的受试者的百分比。 2）容忍最初一天升级至50 mg鸡蛋OIT的受试者的百分比。 3）在研究的脱敏阶段，达到2克维持剂量的受试者的百分比。 假设：每天摄入少量的卵子蛋白会使卵过敏儿童脱敏（增加治疗时摄取卵子的能力），长期治疗后，将诱导耐鸡蛋的耐受能力（在治疗期间永久摄取鸡蛋的能力）。