Study protocol of a phase 2, dual-centre, randomised, controlled trial evaluating the effectiveness of probiotic and egg oral immunotherapy at inducing desensitisation or sustained unresponsiveness (remission) in participants with egg allergy compared with placebo (Probiotic Egg Allergen Oral Immunotherapy for Treatment of Egg Allergy: PEAT study)

Introduction Egg allergy is the most common food in children but recent studies have shown persistence or delayed resolution into adolescence. As there currently no effective long-term treatment, definitive treatments that improve quality of life and prevent fatalities for allergies are required. We previously a novel treatment comprising combination probiotic Lactobacillus rhamnosus CGMCC 1.3724 with peanut oral immunotherapy (OIT) highly at inducing sustained unresponsiveness, benefit persisting to 4 years after cessation majority initial responders. In this study, we plan extend OIT platform another allergen, namely egg. describe protocol phase 2, dual-centre, randomised, controlled trial evaluating effectiveness egg desensitisation unresponsiveness (remission) participants compared placebo. Methods analysis 80 aged 5–30 age current confirmed by double-blind placebo-controlled challenge study screening will be recruited from Australia Singapore. There two intervention arms—probiotic (active) Interventions administered once daily 18 months. The primary outcome proportion who attain 8-week active group versus placebo group. Ethics dissemination This has been approved Human Research Committees Royal Children’s Hospital (HREC 2019.082) National Healthcare Group Domain Specific Review Board (2019/00029). Results published peer-reviewed journals disseminated via presentations international conferences. Trial registration number ACTRN12619000480189.