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Clinical Trials/NCT06038019
NCT06038019RecruitingNot Applicable

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

Hamilton Health Sciences Corporation1 site in 1 country2,000 target enrollmentStarted: November 1, 2023Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
2,000
Locations
1
Primary Endpoint
Eliciting dose thresholds to food challenge
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Other
Time Perspective
Prospective

Eligibility Criteria

Ages
3 Months to 65 Years (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Outcomes

Primary Outcomes

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 Outcomes

  • Food Allergy Quality of Life Questionnaire Parent Form(1 year)
  • Specific IgE(1 year)
  • Food Allergy Quality of Life Questionnaire Teen Form(1 year)
  • Food Allergy Quality of Life Questionnaire Child Form(1 year)
  • Food Allergy Quality of Life Questionnaire Adult Form(1 year)
  • Skin Prick Testing(1 year)
  • Basophil Activation Test(1 year)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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Thresholds In Food Allergy evaluaTion And... | Clinical Trial