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Recruiting NCT06038019

Thresholds In Food Allergy evaluaTion And predictioN

— Observational Tree Nut Allergy Food Allergy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Oral food challenge.
Who it may be relevant to
Registry conditions: Tree Nut Allergy, Food Allergy. Basic parameters: 3 months — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Thresholds In Food Allergy evaluaTion And predictioN, a Prospective, Multicentre Registry Study

Overview

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.

Interventions

  • Diagnostic test Oral food challenge
    Patients will undergo oral food challenge with increasing amounts of food allergen

Primary outcome measures

  • Eliciting dose thresholds to food challenge [Time frame: 1 year]
Secondary outcome measures (7)
  • Food Allergy Quality of Life Questionnaire Child Form [Time frame: 1 year]
  • Food Allergy Quality of Life Questionnaire Teen Form [Time frame: 1 year]
  • Food Allergy Quality of Life Questionnaire Adult Form [Time frame: 1 year]
  • Food Allergy Quality of Life Questionnaire Parent Form [Time frame: 1 year]
  • Skin Prick Testing [Time frame: 1 year]
  • Specific IgE [Time frame: 1 year]
  • Basophil Activation Test [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Other

Study locations

Canada · 1 center
  • McMaster University Medical Centre — Hamilton

Identifiers

NCT: NCT06038019 · NIF-20500

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗