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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06038019
Other study ID # NIF-20500
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 1, 2023
Est. completion date January 1, 2051

Study information

Verified date May 2024
Source Hamilton Health Sciences Corporation
Contact Heather Le
Phone 905-525-9140
Email lehea@hhsc.ca
Is FDA regulated No
Health authority
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.

Study Design


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
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