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)

Loke, Paxton, Chebar Lozinsky, Adriana, Orsini, Francesca, Wong, Lydia Su-Yin, Leung, Agnes Sze-Yin, Tham, Elizabeth Huiwen, Lopata, Andreas L., Shek, Lynette Pei-Chi, and Tang, Mimi L.K. (2021) 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). BMJ Open, 11 (7). e044331.

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Abstract

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

Item ID: 70268
Item Type: Article (Scholarly Work)
ISSN: 2044-6055
Keywords: Allergy, Clinical trials, IMMUNOLOGY
Copyright Information: © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
Funders: National Health and Medical Research Council (NHMRC)
Date Deposited: 09 Feb 2022 01:16
FoR Codes: 32 BIOMEDICAL AND CLINICAL SCIENCES > 3204 Immunology > 320401 Allergy @ 50%
32 BIOMEDICAL AND CLINICAL SCIENCES > 3213 Paediatrics > 321301 Adolescent health @ 20%
31 BIOLOGICAL SCIENCES > 3101 Biochemistry and cell biology > 310109 Proteomics and intermolecular interactions (excl. medical proteomics) @ 30%
SEO Codes: 20 HEALTH > 2005 Specific population health (excl. Indigenous health) > 200502 Health related to ageing @ 50%
28 EXPANDING KNOWLEDGE > 2801 Expanding knowledge > 280112 Expanding knowledge in the health sciences @ 50%
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