Last updated: February 12, 2024
Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Overall Status: Active - Recruiting
Phase
N/A
Condition
Allergies & Asthma
Allergy
Allergy (Pediatric)
Treatment
Food allergy desensitization / Oral Immunotherapy
Clinical Study ID
NCT06256146
2022-8424
Ages 2-40 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- A history suggestive of immediate allergy to the food. A convincing clinical historyof an IgE mediated reaction to a specific food will be defined as a minimum of 2 mildsigns/symptoms or 1 moderate or 1 severe sign/symptom that was likely IgE mediated andoccurred within 120 minutes after ingestion or contact
- The presence of at least one of the following confirmatory tests:
- Positive SPT to the culprit food allergen (weal diameter 3 mm larger than that ofthe normal saline control). The allergens used will be commercial extracts of thefoods (Omega Labs, Toronto, Ontario).
- Detection of serum specific IgE (>0.35 kU/L) to the culprit food or any of itsproteins, measured by fluorescence enzyme immunoassay (Phadia, CAP System,Uppsala, Sweden).
Exclusion
Exclusion Criteria:
- Patients who have uncontrolled respiratory disease (asthma, cystic fibrosis, etc.)
- Patients who present with intercurrent disease active at the time of startingdesensitization.
- Non IgE mediated or non-immunological adverse reactions to milk or peanuts.
- Malignant or immunopathological diseases and/or severe primary or secondary immunedeficiencies.
- Patients receiving oral immunosuppressor therapy.
- Patients receiving β-blockers (including topical formulations), or who receive dailydoses of NSAIDs, aspirin or ACE inhibitors for cardiac issues.
- Associated diseases contraindicating the use of epinephrine: cardiovascular disease,severe hypertension or hypotension.
- Patients diagnosed with eosinophilic gastrointestinal disorders, including patientswith a history of antacid use for reflux related to food impaction or with a historyof esophageal spasm.
- Patients already tolerating processed/cooked forms of the food (e.g.,baked goods withmilk).
Study Design
Total Participants: 360
Treatment Group(s): 1
Primary Treatment: Food allergy desensitization / Oral Immunotherapy
Phase:
Study Start date:
March 01, 2022
Estimated Completion Date:
February 28, 2030
Connect with a study center
Research Institute of the McGill University Health Centre
Montreal, Quebec H4A 3J1
CanadaActive - Recruiting
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