NCT02424136

PEAnut Anaphylaxis Predictors

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: John Hunter Children's Hospital · Academic / Other
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Peanut Hypersensitivity
• Anaphylaxis

Interventions

Type	Name	Description
OTHER	Questionnaire	5 minute questionnaire focused on symptoms of allergic disease
OTHER	Peanut Skin prick test	Skin prick testing with peanut antigen, according to ASCIA Skin Prick testing manual
OTHER	Fraction of exhaled nitric oxide	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).
OTHER	Spirometry	Measurement of lung flows/volumes, according to ATS/ERS standardised procedures (Not required for those age less than 6 years).
OTHER	Serum Peanut and Ara h2 specific immunoglobulin E	Peanut and Ara h2 specific IgE antibodies
OTHER	Collection of blood biomarker	Correlation of blood biomarker levels in patients with successful or unsuccessful peanut food challenge
OTHER	Peanut food challenge	Open label peanut challenge conducted according to ASCIA's peanut challenge protocol and PRACTALL consensus report

Timeline

• Start date: 2015-07-22
• Primary completion: 2018-08-28
• Completion: 2019-12-01
• First posted: 2015-04-22
• Last updated: 2020-01-22

Locations

1 site across 1 country: Australia