Clinical Trials

PEAnut Anaphylaxis Predictors

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	2 Years - 17 Years
Gender	All

More Inclusion & Exclusion Criteria

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).

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT02424136
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	John Hunter Children's Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Joerg Mattes, MD
Principal Investigator Affiliation	John Hunter Children's Hospital, Australia
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, Industry
Overall Status	Recruiting
Countries	Australia
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Peanut Hypersensitivity, Anaphylaxis
Study Website:	View Trial Website

Additional Details

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.

Arms & Interventions

Arms

Other: Entire group

Children aged 2-17 years with suspected peanut allergy who require peanut food challenge to confirm clinical allergy, will be recruited for the study. They will undergo a preceding questionnaire, peanut skin prick testing, spirometry, fraction of exhaled nitric oxide (FeNO) measurement, serum peanut and Ara h2 specific immunoglobulin E (sIgE) antibodies, and collection of blood biomarker prior to food challenge. The primary endpoint will be anaphylaxis at open label peanut challenge, with the primary exposure of interest will be the serum biomarker.

Interventions

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

John Hunter Children's Hospital, New Lambton, New South Wales, Australia

Status

Recruiting

Address

John Hunter Children's Hospital

New Lambton, New South Wales, 2305

Site Contact

Joerg Mattes, MD

Joerg.Mattes@hnehealth.nsw.gov.au

+ 61 2 4985 5277

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