Thresholds In Food Allergy evaluaTion And predictioN

NCT06038019 | Recruiting DMC

• 1 other identifier: NIF-20500
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Tree Nut Allergy; Food Allergy

Keywords

Immunotherapy; Food Allergy; Diagnosis; Prognosis

Outcome Measures

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

  1 year

Secondary Outcomes (7)

• Food Allergy Quality of Life Questionnaire Child Form

  1 year

• Food Allergy Quality of Life Questionnaire Teen Form

  1 year

• Food Allergy Quality of Life Questionnaire Adult Form

  1 year

• Food Allergy Quality of Life Questionnaire Parent Form

  1 year

• Skin Prick Testing

  1 year

Study Arms (1)

Group 1

Patients with suspected or confirmed food allergy

Diagnostic Test: Oral food challenge

Interventions

Oral food challenge DIAGNOSTIC_TEST

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

Group 1

Eligibility Criteria

• Age: 3 Months - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All consecutive patients suspected or confirmed to be food allergic

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead
• AAAAI Foundation: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

McMaster University Medical Centre

Hamilton, Ontario, Canada

RECRUITING

MeSH Terms

Conditions

Nut Hypersensitivity; Food Hypersensitivity; Disease

Condition Hierarchy (Ancestors)

Nut and Peanut Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Derek Chu, MD PhD FRCPC

  Hamilton Health Sciences & McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heather Le

CONTACT

905-525-9140; lehea@hhsc.ca

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2023
• First Posted: September 14, 2023
• Study Start: November 1, 2023
• Primary Completion (Estimated): November 1, 2050
• Study Completion (Estimated): January 1, 2051
• Last Updated: June 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)