Peanut Allergen Threshold Study (PATS): validation of eliciting doses using a novel single-dose challenge protocol

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dc.contributor.authorZurzolo, Giovanni A.
dc.contributor.authorAllen, Katrina J.
dc.contributor.authorTaylor, Steve L.
dc.contributor.authorShreffler, Wayne G.
dc.contributor.authorBaumert, Joseph L.
dc.contributor.authorTang, Mimi L. K.
dc.contributor.authorGurrin, Lyle C.
dc.contributor.authorMathai, Michael L.
dc.contributor.authorNordlee, Julie A.
dc.contributor.authorDunn Galvin, Audrey
dc.contributor.authorHourihane, Jonathan O'B.
dc.date.accessioned2013-12-04T17:29:03Z
dc.date.available2013-12-04T17:29:03Z
dc.date.copyright2013
dc.date.issued2013-09-12
dc.date.updated2013-09-19T09:24:03Z
dc.description.abstractBackground: The eliciting dose (ED) for a peanut allergic reaction in 5% of the peanut allergic population, the ED05, is 1.5 mg of peanut protein. This ED05 was derived from oral food challenges (OFC) that use graded, incremental doses administered at fixed time intervals. Individual patients’ threshold doses were used to generate population dose-distribution curves using probability distributions from which the ED05 was then determined. It is important to clinically validate that this dose is predictive of the allergenic response in a further unselected group of peanut-allergic individuals. Methods/Aims: This is a multi-centre study involving three national level referral and teaching centres. (Cork University Hospital, Ireland, Royal Children’s Hospital Melbourne, Australia and Massachusetts General Hospital, Boston, U.S.A.) The study is now in process and will continue to run until all centres have recruited 125 participates in each respective centre. A total of 375 participants, aged 1–18 years will be recruited during routine Allergy appointments in the centres. The aim is to assess the precision of the predicted ED05 using a single dose (6 mg peanut = 1.5 mg of peanut protein) in the form of a cookie. Validated Food Allergy related Quality of Life Questionnaires-(FAQLQ) will be self-administered prior to OFC and 1 month after challenge to assess the impact of a single dose OFC on FAQL. Serological and cell based in vitro studies will be performed. Conclusion: The validation of the ED05 threshold for allergic reactions in peanut allergic subjects has potential value for public health measures. The single dose OFC, based upon the statistical dose-distribution analysis of past challenge trials, promises an efficient approach to identify the most highly sensitive patients within any given food-allergic population.en
dc.description.statusPeer revieweden
dc.description.versionPublished Versionen
dc.format.mimetypeapplication/pdfen
dc.identifier.citationZURZOLO, G. A., ALLEN, K. J., TAYLOR, S. L., SHREFFLER, W. G., BAUMERT, J. L., TANG, M. L. K., GURRIN, L. C., MATHAI, M. L., NORDLEE, J. A., DUNNGALVIN, A., HOURIHANE, J . O'B. 2013. Peanut Allergen Threshold Study (PATS): validation of eliciting doses using a novel single-dose challenge protocol. Allergy, Asthma & Clinical Immunology 2013 9 :35 doi: 10.1186/1710-1492-9-35en
dc.identifier.doi10.1186/1710-1492-9-35
dc.identifier.journaltitleAllergy, Asthma & Clinical Immunologyen
dc.identifier.startpage35en
dc.identifier.urihttps://hdl.handle.net/10468/1273
dc.identifier.volume9en
dc.language.isoenen
dc.publisherBioMed Centralen
dc.relation.urihttp://www.aacijournal.com/content/9/1/35
dc.rights© 2013 Zurzolo et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.en
dc.rights.urihttp://creativecommons.org/licenses/by/2.0en
dc.subjectEliciting dose (ED)en
dc.subjectFood Allergy related Quality of Life Questionnaires-(FAQLQ)en
dc.subjectSingle doseen
dc.subjectPeanut thresholdsen
dc.subjectOral Food Challenges (OFC)en
dc.subjectVoluntary Incidental Trace Allergen Labelling (VITAL)en
dc.subjectPeanut Allergen Threshold Study (PATS)en
dc.titlePeanut Allergen Threshold Study (PATS): validation of eliciting doses using a novel single-dose challenge protocolen
dc.typeArticle (peer-reviewed)en
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