PEAnut Anaphylaxis Predictors
Condition: Peanut Hypersensitivity; Anaphylaxis
MeSH terms: Hypersensitivity; Anaphylaxis; Peanut Hypersensitivity; Shock
Study type: Interventional

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 description: 
      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.
    

Intervention name(s): Questionnaire; Peanut Skin prick test; Fraction of exhaled nitric oxide; Spirometry; Serum Peanut and Ara h2 specific immunoglobulin E; Collection of blood biomarker; Peanut food challenge
Intervention type(s): Other; Other; Other; Other; Other; Other; Other
Intervention description(s): 5 minute questionnaire focused on symptoms of allergic disease; Skin prick testing with peanut antigen, according to ASCIA Skin Prick testing manual; Measurement of exhaled nitric oxide, according to American Thoracic Society/ European Thoracic Society (ATS/ERS) standardised procedures (Not required for those age less than 6 years).; Measurement of lung flows/volumes, according to ATS/ERS standardised procedures (Not required for those age less than 6 years).; Peanut and Ara h2 specific IgE antibodies; Correlation of blood biomarker levels in patients with successful or unsuccessful peanut food challenge; Open label peanut challenge conducted according to ASCIA's peanut challenge protocol and PRACTALL consensus report
Intervention MeSH terms: Nitric Oxide; Immunoglobulins; Immunoglobulins, Intravenous; Antibodies
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic