Investigating Modified Protocols of Oral Immunotherapy to Validate Efficacy and Safety

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

Protocols for Oral Immunotherapy (OIT) for the main food allergens have been recently incorporated in clinical practice for food allergies and their clinical benefits have been acknowledged in European and Canadian official guidelines. There has been some reluctance in both clinicians and patients to implement these therapies, primarily because of the risk of allergic reactions during the desensitization process. This study will investigate if protocols using low doses of a food allergen or processed versions of the allergen can be both effective in conferring desensitization while inducing fewer allergic symptoms during the desensitization process.

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
    Canada

    Active - Recruiting

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