Actively Recruiting

Phase Not Applicable
Age: 2Years - 40Years
All Genders
NCT06256146

Investigating Modified Protocols of Oral Immunotherapy to Validate Efficacy and Safety

Led by McGill University Health Centre/Research Institute of the McGill University Health Centre · Updated on 2026-05-07

360

Participants Needed

1

Research Sites

417 weeks

Total Duration

On this page

Sponsors

M

McGill University Health Centre/Research Institute of the McGill University Health Centre

Lead Sponsor

T

The Hospital for Sick Children

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Investigating Modified Protocols of Oral Immunotherapy to Validate Efficacy and Safety

Who Can Participate

Age: 2Years - 40Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • History of immediate allergy to the food with at least 2 mild or 1 moderate or severe symptoms occurring within 120 minutes after exposure
  • Positive skin prick test to the allergen with wheal size at least 3 mm larger than control
  • Detectable serum specific IgE to the allergen or its proteins measured by immunoassay
Not Eligible

You will not qualify if you...

  • Uncontrolled respiratory diseases such as asthma or cystic fibrosis
  • Active illness present when starting desensitization
  • Non-IgE or non-immunological reactions to milk or peanuts
  • Malignant or immune system diseases including severe immune deficiencies
  • Use of oral immunosuppressor therapy
  • Use of beta-blockers, daily NSAIDs, aspirin, or ACE inhibitors for heart problems
  • Cardiovascular disease or severe blood pressure problems contraindicating epinephrine use
  • Eosinophilic gastrointestinal disorders or history of reflux-related esophageal issues
  • Already tolerating cooked or processed forms of the allergenic food

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Research Institute of the McGill University Health Centre

Montreal, Quebec, Canada, H4A 3J1

Actively Recruiting

Loading map...

Research Team

D

Duncan Lejtenyi, M.Sc

CONTACT

L

Liane Beaudette, RN

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here