Safer oral immunotherapy with very low-dose introduction for pediatric hen's egg allergy.

Background: Adverse events could be a barrier to implementing oral immunotherapy (OIT) in children with hen's egg (HE) allergy, highlighting the need for safer OIT methods. Objective: To determine the safety and efficacy of a new OIT method in a single-center, phase II, double-blind, parallel-group, randomized controlled trial. Methods: Children aged 1 to 18 years with HE allergy whose cumulative tolerated dose (CTD) range was greater than or equal to 0.1 g to less than 10 g in the oral food challenge test were randomly assigned to the experimental therapy (ET) group with a very low starting dose or to the standard therapy (ST) group with a fixed-quantity maintenance dose for OIT. The primary outcome was safety, measured by days on OIT before the first IgE-mediated immediate-type reaction. The OIT efficacy, the change in CTD, was to be evaluated. Results: Among 20 participants at registration, 12 (60%) and 8 (40%) participants were allocated to the ET and ST groups, respectively. Although the study was prematurely terminated because of difficulty in the safe supply of immunotherapy food, the number of days before the first IgE-mediated immediate-type reaction was more in the ET group than in the ST group ( Conclusions: OIT with a very low starting dose might be a safer approach with a low treatment burden for children with HE allergies.