Peanut Hypersensitivity, Anaphylaxis
Conditions
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 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.
Interventions
OTHERQuestionnaire
5 minute questionnaire focused on symptoms of allergic disease
OTHERPeanut Skin prick test
Skin prick testing with peanut antigen, according to ASCIA Skin Prick testing manual
OTHERFraction 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).
OTHERSpirometry
Measurement of lung flows/volumes, according to ATS/ERS standardised procedures (Not required for those age less than 6 years).
OTHERSerum Peanut and Ara h2 specific immunoglobulin E
Peanut and Ara h2 specific IgE antibodies
OTHERCollection of blood biomarker
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
Sponsors
Hunter Medical Research Institute, Australia
University of Newcastle, Australia
Thrasher Research Fund
Hunter Childrens Research Foundation, Australia
Aerocrine AB
John Hunter Children's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Children aged 2 - 17 years with an allergy to peanut and require peanut challenge to confirm peanut allergy.
Exclusion criteria
* Children with Peanut Skin Prick Test (SPT) wheal size greater than 10mm as these children are likely to have clinical peanut allergy (no clinical indication for food challenge).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood biomarker predicting anaphylaxis at peanut food challenge | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood biomarker in combination with FeNO, and/or Ara h2 sIgE predicting anaphylaxis at peanut food challenge | 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. |
Countries
Australia
Outcome results
None listed