Thresholds In Food Allergy evaluaTion And predictioN

Study Overview
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Brief Summary
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Thresholds In food allergy evaluaTion And predictioN, a prospective, observational registry. The aim is to quantify food allergy thresholds in Canada and their clinical predictors.

Official Title
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Thresholds In Food Allergy evaluaTion And predictioN, a Prospective, Multicentre Registry Study

Conditions
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Tree Nut Allergy, Food Allergy

Intervention / Treatment
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* Diagnostic Test: Oral food challenge


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Suspicion or history of food allergy based on medical history, positive skin prick test, and/or serum food-specific IgE. A suggestive history is defined as typical clinical signs and/or symptoms (urticaria, angioedema, abdominal pain, vomiting, dyspnea, wheeze) within 60 minutes of the ingestion of a food. Ability to discontinue all antihistamines for 1 week before oral food challenge. Exclusion Criteria: Previous desensitization treatment to a food allergen Allergies to any component of the oral challenge vehicle Unstable conditions including uncontrolled asthma or chronic urticaria Any clinically significant disease/chronic medical condition which may interfere with study evaluations.

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Patients with suspected or confirmed food allergy | Diagnostic Test: Oral food challenge<br>* Patients will undergo oral food challenge with increasing amounts of food allergen<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eliciting dose thresholds to food challenge | Threshold are measured by controlled food challenge to incremental doses of allergen (g) and are adjudicated according to CoFAR v3.0 criteria | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Food Allergy Quality of Life Questionnaire Child Form | The number of items found in the child form questionnaire includes 30 items. Food allergy quality of life questionnaire is answered on a 7-point scale (0 to 6) with higher scores representing worse impairment. | 1 year | 
| Food Allergy Quality of Life Questionnaire Teen Form | The number of items found in the Teen Form questionnaire includes 26 items. Food allergy quality of life questionnaire is answered on a 7-point scale (0 to 6) with higher scores representing worse impairment. | 1 year | 
| Food Allergy Quality of Life Questionnaire Adult Form | The number of items found in the Adult Form questionnaire includes 35 items. Food allergy quality of life questionnaire is answered on a 7-point scale (0 to 6) with higher scores representing worse impairment. | 1 year | 
| Food Allergy Quality of Life Questionnaire Parent Form | The number of items found in the Parent Form questionnaire includes 38 items. Food allergy quality of life questionnaire consists of 3 to 4 domains, each question is answered on a 7-point scale (0 to 6) with higher scores representing worse impairment. | 1 year | 
| Skin Prick Testing | Measured by mean wheal size (mm) | 1 year | 
| Specific IgE | Measured by ImmunoCap (kU/L) | 1 year | 
| Basophil Activation Test | Measured by flow cytometry (cell frequency basophils and median fluorescence intensity) | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immunotherapy, Food Allergy, Diagnosis, Prognosis