Thresholds In Food Allergy evaluaTion And predictioN

Recruiting

• Conditions: Food Allergy; Tree Nut Allergy
• Interventions: Diagnostic Test: Oral food challenge

• Registration Number: NCT06038019
• Lead Sponsor: Hamilton Health Sciences Corporation

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-18
• Study First Submitted QC: 2023-09-07
• Study First Posted: 2023-09-14
• Study Start: 2023-11-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-30
• Last Update Posted: 2024-06-03
• Primary Completion: 2050-11-01
• Study Completion: 2051-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Oral food challenge	Patients with suspected or confirmed food allergy

Primary Outcome Measures

Name	Time	Method
Eliciting dose thresholds to food challenge	1 year	Threshold are measured by controlled food challenge to incremental doses of allergen (g) and are adjudicated according to CoFAR v3.0 criteria

Secondary Outcome Measures

Name	Time	Method
Food Allergy Quality of Life Questionnaire Parent Form	1 year	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.
Specific IgE	1 year	Measured by ImmunoCap (kU/L)
Food Allergy Quality of Life Questionnaire Teen Form	1 year	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.
Food Allergy Quality of Life Questionnaire Child Form	1 year	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.
Food Allergy Quality of Life Questionnaire Adult Form	1 year	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.
Skin Prick Testing	1 year	Measured by mean wheal size (mm)
Basophil Activation Test	1 year	Measured by flow cytometry (cell frequency basophils and median fluorescence intensity)

Trial Locations

Locations (1)

McMaster University Medical Centre; 🇨🇦 Hamilton, Ontario, Canada