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NCT Number: NCT06038019

Thresholds In Food Allergy evaluaTion And predictioN

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.

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Key information

Conditions

Tree Nut Allergy Disease Food Allergy Food Hypersensitivity Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nut Hypersensitivity Nut and Peanut Hypersensitivity Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

3 month–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

McMaster University Medical Centre

Hamilton, Ontario, Canada

Location status: Recruiting

Location contact

Heather Le

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oral food challenge

Diagnostic Test

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

Primary outcomes

  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 outcomes

  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)

Study contacts

Contact information is provided by the study sponsor or research team.

Heather Le

CONTACT

[email protected]

905-525-9140 ext. 75153

Sponsors and collaborators

Lead sponsor

Hamilton Health Sciences Corporation

Other

Collaborators

  • AAAAI Foundation
  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

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

Acronym: TITAN

Important dates

Study start
2023
Primary completion
2050
Study completion
2051
First posted
Sep 14, 2023
Registry last updated
Jun 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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