METHODS
Study design and eligibility
This was an open-label, single-arm study of PPOIT for 18-months in 20 children aged 1-12 years with peanut allergy confirmed by failed DBPCFC (up to cumulative 4950mg peanut protein) and positive peanut SPT (≥3mm) or peanut sIgE (≥0.35 kUA/L). Pre-determined DBPCFC stopping criteria were applied (supporting information). This study was approved by the Royal Children’s Hospital Human Research and Ethics Committee (reference number 35207). Prospective registration was with Australian New Zealand Clinical Trials Registry (ACTRN12615001275550). All participants provided informed consent.
Intervention
On Day 1, participants received increasing doses of peanut OIT (12% defatted peanut flour, 50% peanut protein; Golden Peanut Company) every 20-minutes to reach a final dose of 12mg peanut protein (24mg cumulative). A single daily dose of probiotic (2 ×1010 cfu Lactobacillus rhamnosusGG ATCC 53103) was also administered. During the subsequent buildup phase, the daily treatment dose was increased every 2-weeks until a maintenance OIT dose of 2000mg peanut protein was reached. Participants continued on a daily maintenance dose of 2000mg peanut protein until completion of 18-months of PPOIT.