Clinical Trial: PEAnut Anaphylaxis Predictors

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: PEAnut Anaphylaxis Predictors

Brief Summary: 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.

Detailed Summary:

Children aged 6-17 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 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.


Sponsor: John Hunter Children's Hospital

Current Primary Outcome: Blood biomarker predicting anaphylaxis at peanut food challenge [ Time Frame: At completion of peanut food challenge ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome: Blood biomarker in combination with FeNO, and/or Ara h2 sIgE predicting anaphylaxis at peanut food challenge [ Time Frame: At completion of peanut food challenge ]

The secondary outcome will be to determine the value of the biomarker, FeNO and Ara h2 sIgE (individually and in combination) at predicting anaphylaxis or clinical allergy at open label peanut challenge.


Original Secondary Outcome: Same as current

Information By: John Hunter Children's Hospital

Dates:
Date Received: April 19, 2015
Date Started: July 2015
Date Completion: December 2019
Last Updated: September 5, 2016
Last Verified: September 2016