Thresholds In Food Allergy evaluaTion And predictioN
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age3-65
SponsorHamilton Health Sciences Corporation
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
All consecutive patients suspected or confirmed to be food allergic
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Oral food challenge
Diagnostic testPatients will undergo oral food challenge with increasing amounts of food allergen
Treatment groups
2,000 Participants
are divided into 1 treatment groupGroup A: Group 11 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
1 yearSecondary outcomes
1
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.
Time frame
1 year2
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.
Time frame
1 year3
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.
Time frame
1 year4
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.
Time frame
1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Hamilton Health Sciences Corporation
Lead sponsor
AAAAI Foundation
Collaborator
Canadian Institutes of Health Research (CIHR)
Collaborator
Source ClinicalTrials.gov