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Peanut Allergen Threshold Study (PATS): validation of eliciting doses using a novel single-dose challenge protocol
Giovanni A Zurzolo1, Katrina J Allen, Steve L Taylor
1Paediatrics and Child Health, University College, Cork, Ireland. J.Hourihane@ucc.ie.
Summary
This study validates the 1.5 mg peanut protein eliciting dose 05 (ED05) for peanut allergy. A single oral food challenge (OFC) dose aims to efficiently identify highly sensitive individuals.
Area of Science:
- Allergy and Immunology
- Clinical Trials
- Food Science
Background:
- The established eliciting dose 05 (ED05) for peanut allergy is 1.5 mg peanut protein, determined by graded oral food challenges (OFC).
- Clinical validation is needed to confirm the ED05's predictive accuracy in diverse peanut-allergic populations.
Purpose of the Study:
- To clinically validate the predictive precision of the established ED05 (1.5 mg peanut protein) for eliciting allergic reactions.
- To assess the impact of a single-dose OFC on the quality of life in peanut-allergic children and adolescents.
Main Methods:
- A multi-center study involving 375 participants aged 1-18 years undergoing routine allergy appointments.
- Participants will receive a single 6 mg peanut dose (equivalent to 1.5 mg peanut protein) in cookie form for OFC.
- Validated Food Allergy Quality of Life Questionnaires (FAQLQ) will assess quality of life pre- and post-challenge; serological and in vitro studies will also be performed.
Main Results:
- Study is currently in process, with recruitment ongoing across three international centers.
- Data collection includes OFC outcomes, FAQLQ scores, and results from serological and in vitro assays.
Conclusions:
- Validation of the ED05 threshold holds significant public health implications for managing peanut allergy.
- A single-dose OFC approach, informed by statistical analysis, offers an efficient method for identifying highly sensitive individuals within the peanut-allergic population.
