Anaphylaxis Clinical Trial
Official title:
PEAnut Anaphylaxis Predictors
Peanut allergy can be life-threatening. Current diagnostic techniques for peanut allergy have high sensitivity, but not high specificity. This clinical trial will test the validity of a novel blood biomarker (compared with current testing) as a diagnostic predictor of anaphylaxis to peanut.
Children aged 2-17 years with suspected peanut allergy will be invited to participate in the
study.
They will have a questionnaire, a skin prick test to peanut, 2 breathing tests (spirometry
and fraction of exhaled nitric oxide (FeNO)), and a blood test (specific peanut antibodies,
allergic immune responses - including the novel blood biomarker - and genetic testing to
identify novel potential molecular and genetic markers of food allergy in the future. The
genetic testing component will be optional). The breathing test is not required for those
under 6 years.
The final step is an open label peanut food challenge with incremental doses of peanut,
(routine practise) as per the Australasian Society of Clinical Immunology and Allergy (ASCIA)
food challenge protocol.The endpoints in the food challenge will be signs of allergy or
anaphylaxis as per PRACTicing ALLergology (PRACTALL) consensus report for oral food
challenges OR completion of the ASCIA food challenge protocol.
Outcome: The primary outcome of the project is to confirm that a novel blood biomarker has a
higher diagnostic accuracy as compared to current best testing in predicting anaphylaxis at
open label peanut challenge.
Secondary outcome: Will be to determine the value of the biomarker, FeNO and Ara h2 specific
Immunoglobulin E (sIgE) (individually and in combination) at predicting anaphylaxis or
clinical allergy at open label peanut challenge.
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