ClinicalTrials.gg
RecruitingNCT06038019TITANUpdated Jun 3, 2024

Thresholds In Food Allergy evaluaTion And predictioN

An observational study in Tree Nut Allergy and Food Allergy, sponsored by Hamilton Health Sciences Corporation. Recruiting at 1 site in Canada. Open to participants aged 3 Months to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-03.

Sponsored by Hamilton Health Sciences Corporation · Observational

From the registry’s dates

  • Started Nov 2023; still recruiting 3 years later.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
2,000
Ages
3 Months to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Tree Nut Allergy
  • Food Allergy

Keywords

  • Immunotherapy
  • Food Allergy
  • Diagnosis
  • Prognosis
03

In context

Nut Hypersensitivity

33 studies on the registry are indexed under Nut Hypersensitivity; 9 are open to participants now.

This study's planned enrollment of 2,000 is above the median of 240 across 11 observational studies indexed under Nut Hypersensitivity.

Browse Nut Hypersensitivity studies →

Lead sponsor

Hamilton Health Sciences Corporation is the lead sponsor of 242 studies on the registry; 38 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Months to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

All consecutive patients suspected or confirmed to be food allergic

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 disease/chronic medical condition which may interfere with study evaluations.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
2,000 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • Group 1

    Patients with suspected or confirmed food allergy

    Diagnostic Test: Oral food challenge

Interventions

  • Diagnostic testOral food challenge

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

06

What researchers measure

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

    Time frame: 1 year

Secondary outcomes

  1. Food Allergy Quality of Life Questionnaire Child Form

    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.

    Time frame: 1 year

  2. Food Allergy Quality of Life Questionnaire Teen Form

    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.

    Time frame: 1 year

  3. Food Allergy Quality of Life Questionnaire Adult Form

    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.

    Time frame: 1 year

  4. Food Allergy Quality of Life Questionnaire Parent Form

    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.

    Time frame: 1 year

  5. Skin Prick Testing

    Measured by mean wheal size (mm)

    Time frame: 1 year

  6. Specific IgE

    Measured by ImmunoCap (kU/L)

    Time frame: 1 year

  7. Basophil Activation Test

    Measured by flow cytometry (cell frequency basophils and median fluorescence intensity)

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No — Will consider on a case by case basis.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06038019
Collaborators
AAAAI Foundation, Canadian Institutes of Health Research (CIHR)
Responsible party
Sponsor
First posted
Sep 14, 2023
Start date
Nov 1, 2023
Primary completion
Nov 1, 2050 (estimated)
Completion
Jan 1, 2051 (estimated)
Last update
Jun 3, 2024

Study contacts

Heather Le
Contact
lehea@hhsc.ca
905-525-9140 ext. 75153
Derek Chu, MD PhD FRCPC
principal investigator · Hamilton Health Sciences & McMaster University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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