Thresholds In Food Allergy evaluaTion And predictioN

Food Allergy Clinical Trial

— TITAN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06038019
• Other study ID #: NIF-20500
• Status: Recruiting
• Start date: November 1, 2023
• Est. completion date: January 1, 2051

Study information

• Verified date: September 2023
• Source: Hamilton Health Sciences Corporation
• Contact: Heather Le
• Phone: 905-525-9140
• Email: lehea[@]hhsc.ca
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: January 1, 2051
• Est. primary completion date: November 1, 2050
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Months to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Food Allergy
• Food Hypersensitivity
• Hypersensitivity
• Nut Hypersensitivity
• Tree Nut Allergy

Intervention

Diagnostic Test:
• Oral food challenge
Patients will undergo oral food challenge with increasing amounts of food allergen

Locations

Country	Name	City	State
Canada	McMaster University Medical Centre	Hamilton	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation	AAAAI Foundation, Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Skin Prick Testing	Measured by mean wheal size (mm)	1 year
Secondary	Specific IgE	Measured by ImmunoCap (kU/L)	1 year
Secondary	Basophil Activation Test	Measured by flow cytometry (cell frequency basophils and median fluorescence intensity)	1 year