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. 2023 Mar;34(3):e13930.
doi: 10.1111/pai.13930.

TreEAT trial: Protocol for a randomized 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

Vicki L McWilliam  1   2   3 , Jennifer J Koplin  1   3 , Katie Allen  1   4 , Marnie Robinson  2 , Joanne Smart  2 , Paxton Loke  2   3   5 , Rachel L Peters  1   3 , Thanh Dang  1   3 , Katherine J Lee  3   6   7 , Kim Dalziel  8 , Dean Tey  2 , Mark Taranto  2 , Kirsten P Perrett  1   2   3   7   9
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TreEAT trial: Protocol for a randomized 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

Vicki L McWilliam et al. Pediatr Allergy Immunol. 2023 Mar.

Abstract

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 with 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, randomized, controlled trial (RCT). Infants (n = 212) aged 4-11 months with peanut allergy will be randomized 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 18 months, with questionnaires and SPT to peanut and tree nuts. Peanut and tree nut OFCs will be performed as required to determine the 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 randomization 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: NCT04801823.

Keywords: allergy prevention; food allergy; nut allergy; tree nut.

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References

REFERENCES

    1. Eigenmann PA, Lack G, Mazon A, et al. Managing nut allergy: a remaining clinical challenge. J Allergy Clin Immunol Pract. 2016;5(2):296-300.
    1. McWilliam V, Peters R, Tang MLK, et al. Patterns of tree nut sensitization and allergy in the first 6 years of life in a population-based cohort. J Allergy Clin Immunol. 2018;143:644-650.
    1. Sasaki M, Koplin JJ, Dharmage SC, et al. Prevalence of clinic-defined food allergy in early adolescence: the SchoolNuts study. J Allergy Clin Immunol. 2017;141:391-398.
    1. McWilliam VL, Perrett KP, Dang T, Peters RL. Prevalence and natural history of tree nut allergy. Ann Allergy Asthma Immunol. 2020;124(5):466-472.
    1. Mullins RJ, Wainstein BK, Barnes EH, Liew WK, Campbell DE. Increases in anaphylaxis fatalities in Australia from 1997 to 2013. Clin Exp Allergy. 2016;46(8):1099-1110.

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