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.