Thresholds In Food Allergy evaluaTion And predictioN

Hamilton Health Sciences Corporation2,000 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

2,000

Conditions

Tree Nut Allergy Food Allergy

Interventions

Oral food challengeDIAGNOSTIC_TEST

Patients will undergo oral food challenge with increasing amounts of food allergen

Eligibility

Sex: ALLMin age: 3 MonthsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. 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. 2. Ability to discontinue all antihistamines for 1 week before oral food challenge. Exclusion Criteria: 1. Previous desensitization treatment to a food allergen 2. Allergies to any component of the oral challenge vehicle 3. Unstable conditions including uncontrolled asthma or chronic urticaria 4. Any clinically significant disease/chronic medical condition which may interfere with study evaluations.

Locations (1)

McMaster University Medical Centre

Hamilton, Ontario, Canada

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: 1 year

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 1 year

Skin Prick Testing

Measured by mean wheal size (mm)

Time frame: 1 year

Central Contacts

Heather Le

CONTACT

905-525-9140 lehea@hhsc.ca

Data from ClinicalTrials.gov

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