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

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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).