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Thresholds In Food Allergy evaluaTion And predictioN (TITAN)

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ClinicalTrials.gov Identifier: NCT06038019
Recruitment Status : Recruiting
First Posted : September 14, 2023
Last Update Posted : June 3, 2024
Sponsor:
Collaborators:
AAAAI Foundation
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Hamilton Health Sciences Corporation

Study Description
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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.

Condition or disease Intervention/treatment
Tree Nut Allergy Food Allergy Diagnostic Test: Oral food challenge

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 2000 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Thresholds In Food Allergy evaluaTion And predictioN, a Prospective, Multicentre Registry Study
Actual Study Start Date : November 1, 2023
Estimated Primary Completion Date : November 1, 2050
Estimated Study Completion Date : January 1, 2051

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Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Eliciting dose thresholds to food challenge [ Time Frame: 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 Outcome Measures :
  1. Food Allergy Quality of Life Questionnaire Child Form [ Time Frame: 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.

  2. Food Allergy Quality of Life Questionnaire Teen Form [ Time Frame: 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.

  3. Food Allergy Quality of Life Questionnaire Adult Form [ Time Frame: 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.

  4. Food Allergy Quality of Life Questionnaire Parent Form [ Time Frame: 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.

  5. Skin Prick Testing [ Time Frame: 1 year ]
    Measured by mean wheal size (mm)

  6. Specific IgE [ Time Frame: 1 year ]
    Measured by ImmunoCap (kU/L)

  7. Basophil Activation Test [ Time Frame: 1 year ]
    Measured by flow cytometry (cell frequency basophils and median fluorescence intensity)


Eligibility Criteria
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Ages Eligible for Study:   3 Months to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All consecutive patients suspected or confirmed to be food allergic
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06038019


Contacts
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Contact: Heather Le 905-525-9140 ext 75153 lehea@hhsc.ca

Locations
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Canada, Ontario
McMaster University Medical Centre Recruiting
Hamilton, Ontario, Canada
Contact: Heather Le         
Sponsors and Collaborators
Hamilton Health Sciences Corporation
AAAAI Foundation
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: Derek Chu, MD PhD FRCPC Hamilton Health Sciences & McMaster University
More Information
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Responsible Party: Hamilton Health Sciences Corporation
ClinicalTrials.gov Identifier: NCT06038019    
Other Study ID Numbers: NIF-20500
First Posted: September 14, 2023    Key Record Dates
Last Update Posted: June 3, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Will consider on a case by case basis.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hamilton Health Sciences Corporation:
Immunotherapy
Food Allergy
Diagnosis
Prognosis
Additional relevant MeSH terms:
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Hypersensitivity
Food Hypersensitivity
Nut Hypersensitivity
 Immune System Diseases
Hypersensitivity, Immediate
Nut and Peanut Hypersensitivity