TITAN: Thresholds In Food Allergy evaluaTion And predictioN

Sponsor

Hamilton Health Sciences Corporation (Other)

Overall Status

Recruiting

CT.gov ID

NCT06038019

Collaborator

AAAAI Foundation (Other), Canadian Institutes of Health Research (CIHR) (Other)

2,000

Enrollment

Location

326

Anticipated Duration (Months)

6.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tree Nut Allergy Food Allergy	Diagnostic Test: Oral food challenge

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

2000 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Nov 1, 2050

Anticipated Study Completion Date :

Jan 1, 2051

Arms and Interventions

Arm	Intervention/Treatment
Group 1 Patients with suspected or confirmed food allergy	Diagnostic Test: Oral food challenge Patients will undergo oral food challenge with increasing amounts of food allergen

Arm

Intervention/Treatment

Group 1

Patients with suspected or confirmed food allergy

Diagnostic Test: Oral food challenge

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

Outcome Measures

Primary Outcome Measures

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

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 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 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.
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.
Skin Prick Testing [1 year]
Measured by mean wheal size (mm)
Specific IgE [1 year]
Measured by ImmunoCap (kU/L)
Basophil Activation Test [1 year]
Measured by flow cytometry (cell frequency basophils and median fluorescence intensity)

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Months to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.