Thresholds In Food Allergy evaluaTion And predictioN (TITAN)

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

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 Overview

• Status: Recruiting
• Conditions: Food Allergy; Tree Nut Allergy
• Intervention / Treatment: Diagnostic test: Oral food challenge

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: Heather Le; Phone Number: 75153 905-525-9140; Email: lehea@hhsc.ca

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada
      • Recruiting
      • McMaster University Medical Centre
      • Contact: Heather Le

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

All consecutive patients suspected or confirmed to be food allergic

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hamilton Health Sciences Corporation
• Collaborators: Canadian Institutes of Health Research (CIHR); AAAAI Foundation
• Investigators: Principal Investigator: Derek Chu, MD PhD FRCPC, Hamilton Health Sciences & McMaster University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Estimated): November 1, 2050
• Study Completion (Estimated): January 1, 2051

Study Registration Dates

• First Submitted: August 18, 2023
• First Submitted That Met QC Criteria: September 7, 2023
• First Posted (Actual): September 14, 2023

Study Record Updates

• Last Update Posted (Actual): June 3, 2024
• Last Update Submitted That Met QC Criteria: May 30, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Prognosis; Immunotherapy; Diagnosis; Food Allergy
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Nut and Peanut Hypersensitivity; Hypersensitivity; Food Hypersensitivity; Nut Hypersensitivity
• Other Study ID Numbers: NIF-20500

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Will consider on a case by case basis.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No