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

Hdl Handle:
http://hdl.handle.net/10147/315441
Title:
Peanut Allergen Threshold Study (PATS): validation of eliciting doses using a novel single-dose challenge protocol
Authors:
Zurzolo, Giovanni A; Allen, Katrina J; Taylor, Steve L; Shreffler, Wayne G; Baumert, Joseph L; Tang, Mimi L K; Gurrin, Lyle C; Mathai, Michael L; Nordlee, Julie A; DunnGalvin, Audrey; Hourihane, Jonathan OB
Citation:
Allergy, Asthma & Clinical Immunology. 2013 Sep 12;9(1):35
Issue Date:
12-Sep-2013
URI:
http://dx.doi.org/10.1186/1710-1492-9-35; http://hdl.handle.net/10147/315441
Abstract:
Abstract Background 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.
Item Type:
Article
Language:
en
Keywords:
FOOD ALLERGY; FOOD AND NUTRITION

Full metadata record

DC FieldValue Language
dc.contributor.authorZurzolo, Giovanni Aen_GB
dc.contributor.authorAllen, Katrina Jen_GB
dc.contributor.authorTaylor, Steve Len_GB
dc.contributor.authorShreffler, Wayne Gen_GB
dc.contributor.authorBaumert, Joseph Len_GB
dc.contributor.authorTang, Mimi L Ken_GB
dc.contributor.authorGurrin, Lyle Cen_GB
dc.contributor.authorMathai, Michael Len_GB
dc.contributor.authorNordlee, Julie Aen_GB
dc.contributor.authorDunnGalvin, Audreyen_GB
dc.contributor.authorHourihane, Jonathan OBen_GB
dc.date.accessioned2014-04-07T09:00:47Z-
dc.date.available2014-04-07T09:00:47Z-
dc.date.issued2013-09-12-
dc.identifier.citationAllergy, Asthma & Clinical Immunology. 2013 Sep 12;9(1):35en_GB
dc.identifier.urihttp://dx.doi.org/10.1186/1710-1492-9-35-
dc.identifier.urihttp://hdl.handle.net/10147/315441-
dc.description.abstractAbstract Background 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.-
dc.language.isoenen
dc.subjectFOOD ALLERGYen_GB
dc.subjectFOOD AND NUTRITIONen_GB
dc.titlePeanut Allergen Threshold Study (PATS): validation of eliciting doses using a novel single-dose challenge protocolen_GB
dc.typeArticleen
dc.language.rfc3066en-
dc.rights.holderGiovanni A Zurzolo et al.; licensee BioMed Central Ltd.-
dc.description.statusPeer Reviewed-
dc.date.updated2014-04-05T11:14:56Z-
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