Thresholds In Food Allergy evaluaTion And predictioN

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06038019

Acronym

TITAN

Enrollment

2000

Registered

2023-09-14

Start date

2023-11-01

Completion date

2051-01-01

Last updated

2024-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Food Allergy, Tree Nut Allergy

Keywords

Immunotherapy, Food Allergy, Diagnosis, Prognosis

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.

Interventions

DIAGNOSTIC_TESTOral food challenge

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

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

3 Months to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
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.
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.
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)
Skin Prick Testing	1 year	Measured by mean wheal size (mm)

Countries

Canada

Contacts

Primary ContactHeather Le

lehea@hhsc.ca905-525-9140

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026