Thresholds In Food Allergy evaluaTion And predictioN

NCT ID: NCT06038019

Last Updated: 2024-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-01

Study Completion Date

2051-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Tree Nut Allergy Food Allergy

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Patients with suspected or confirmed food allergy

Oral food challenge

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Oral food challenge

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

3 Months

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AAAAI Foundation

UNKNOWN

Sponsor Role collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

Hamilton Health Sciences Corporation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Derek Chu, MD PhD FRCPC

Role: PRINCIPAL_INVESTIGATOR

Hamilton Health Sciences & McMaster University

Locations

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McMaster University Medical Centre

Hamilton, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Heather Le

Role: CONTACT

905-525-9140 ext. 75153

Facility Contacts

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Heather Le

Role: primary

Other Identifiers

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NIF-20500

Identifier Type: -

Identifier Source: org_study_id

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