Clinical Trials

Thresholds In Food Allergy evaluaTion And predictioN

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational [Patient Registry]
Eligible Ages	3 Months - 65 Years
Gender	All

More Inclusion & Exclusion Criteria

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:

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 clinically significant disease/chronic medical condition which may interfere with study evaluations.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06038019
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Hamilton Health Sciences Corporation
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Derek Chu, MD PhD FRCPC
Principal Investigator Affiliation	Hamilton Health Sciences & McMaster University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Canada
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Tree Nut Allergy, Food Allergy

Arms & Interventions

Arms

: Group 1

Patients with suspected or confirmed food allergy

Interventions

Diagnostic Test: - Oral food challenge

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

McMaster University Medical Centre, Hamilton, Ontario, Canada

Status

Recruiting

Address

McMaster University Medical Centre

Hamilton, Ontario,

Site Contact

Heather Le

[email protected]

905-525-9140

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