Study protocol of a multicentre, randomised, controlled trial evaluating the effectiveness of probiotic and peanut oral immunotherapy (PPOIT) in inducing desensitisation or tolerance in children with peanut allergy compared with oral immunotherapy (OIT) alone and with placebo (the PPOIT-003 study)
Adriana Chebar Lozinsky, Paxton Loke, Francesca Orsini, Michael O'Sullivan, Susan L. Prescott, Michael S Gold, Patrick Quinn, Audrey DunnGalvin, Mimi LK Tang
BMJ Open | BMJ PUBLISHING GROUP | Published : 2020
INTRODUCTION: Peanut allergy is the the most common cause of life-threatening food-induced anaphylaxis. There is currently no effective long-term treatment. There is a pressing need for definitive treatments that improve the quality of life and prevent fatalities. Allergen oral immunotherapy (OIT) is a promising approach, which is effective at inducing desensitisation; however, OIT has a limited ability to induce sustained unresponsiveness (SU). We have previously shown that a novel treatment comprising a combination of the probiotic Lactobacillus rhamnosus CGMCC 1.3724 with peanut OIT (Probiotic Peanut Oral ImmunoTherapy (PPOIT)) is highly effective at inducing SU, with benefit persisting t..View full abstract
The PPOIT-003 randomised trial is an investigator-initiated study funded by a National Health and Medical Research Council (NHMRC) grant-Australia, Project Grant. The Murdoch Children's Research Institute is the sponsor of the study. Additional funding support was provided by Prota Therapeutics. The probiotic and placebo treatments were provided by Health World Limited as in kind support. Prota Therapeutics and Health World Limited had no input into the study design or in the decision to submit the paper for publication. The Murdoch Children's Research Institute is supported by the Victorian Government's Operational Infrastructure Support Programme.