TreEAT Trial: protocol for a randomised controlled trial investigating
the efficacy and safety of early introduction of tree nuts for the
prevention of tree nut allergy in infants with peanut allergy.
Introduction: Children with peanut allergy are at increased
risk of developing tree nut allergies, which can be severe and for most
lifelong. Introduction of peanut in the first year of life can reduce
the risk of peanut allergy, however, prevention strategies for tree nut
allergies have not been established. We aimed to test the efficacy and
safety of a novel strategy, a supervised multi-nut oral food challenge
(OFC) compared to standard care for tree nut allergy prevention in
infants at high risk of developing tree nut allergy, TreEAT.
Methods and analysis: TreEAT is a 2-armed, open-label,
randomised, controlled trial (RCT). Infants (n=212) aged 4-11months with
peanut allergy will be randomised 1:1 at peanut allergy diagnosis to
either a hospital-based multi-tree nut (almond, cashew, hazelnut and
walnut) OFC using multi-nut butter or standard care (home introduction
of individual tree nuts). All infants will be assessed at age 18months,
with questionnaires and SPT to peanut and tree nuts. Peanut and tree nut
OFCs will be performed as required to determine allergy status for each
nut. The primary outcome is tree nut allergy at age 18 months. Secondary
outcomes include peanut allergy resolution, proportion and severity of
adverse events related to tree nut ingestion, number and frequency of
tree nuts ingested, quality of life and parental anxiety and allergy
related healthcare visits from randomisation to 18 months of age.
Analyses will be performed on an intention-to-treat basis.
Ethics and dissemination TreEAT was approved by the Royal
Children’s Hospital Human Research Ethics Committee (#70489). Outcomes
will be presented at scientific conferences and disseminated through
publication. Trial registration number: ClinicalTrials.gov ID: