Actively Recruiting
Investigating Modified Protocols of Oral Immunotherapy to Validate Efficacy and Safety for Peanut, Milk, and Egg Allergies
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
N/A
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
Researchers are evaluating modified protocols of Oral Immunotherapy (OIT) to treat food allergies to peanut, milk, and egg. The study aims to understand if using low doses or processed versions of these allergens can provide effective desensitization while causing fewer allergic reactions during treatment. This approach addresses concerns about allergic risks that have limited the use of OIT despite its clinical benefits recognized in official guidelines. Participants will be randomly assigned to one of three groups. One group will receive a high maintenance dose of the allergen (1200 mg peanut, 200 ml milk, or 1200 mg egg powder). Another group will receive a lower maintenance dose (120 mg peanut, 50 ml milk, or 300 mg egg powder). The third group will start taking cooked or transformed allergen forms (muffins for egg and milk, Bamba puffs for peanut), then transition to pure allergens, progressing to the same high dose as the first group. During the study, participants will be monitored over three years for allergic reactions, including the rate of anaphylaxis and the effectiveness of the desensitization protocols. Researchers will collect data on safety and response to treatment throughout the dosing process. The study involves regular assessments to track participants' progress and evaluate how well the different approaches work in reducing allergy symptoms.
CONDITIONS
Brief Title
Investigating Modified Protocols of Oral Immunotherapy to Validate Efficacy and Safety
Who Can Participate
Eligibility Criteria
You may qualify if you...
- A history suggestive of immediate allergy to peanut, milk, or egg with at least 2 mild or 1 moderate/severe IgE-mediated symptoms occurring within 120 minutes after ingestion or contact
- Positive skin prick test (SPT) to the culprit food allergen with a wheal diameter 3 mm larger than saline control
- Detection of serum specific IgE (>0.35 kU/L) to the culprit food or its proteins measured by fluorescence enzyme immunoassay
- Age between 2 and 40 years
You will not qualify if you...
- Uncontrolled respiratory diseases such as asthma or cystic fibrosis
- Active intercurrent disease at the time of starting desensitization
- Non IgE-mediated or non-immunological adverse reactions to milk or peanuts
- Malignant or immunopathological diseases and/or severe primary or secondary immune deficiencies
- Receiving oral immunosuppressor therapy
- Taking beta-blockers (including topical), daily NSAIDs, aspirin, or ACE inhibitors for cardiac issues
- Cardiovascular disease or severe hypertension/hypotension contraindicating epinephrine use
- Diagnosed eosinophilic gastrointestinal disorders or history of antacid use for reflux related to food impaction or esophageal spasm
- Already tolerating processed or cooked forms of the food such as baked goods containing milk
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 3 years
Participants consume increasing doses of allergenic food daily until they reach a maintenance dose, following one of three oral immunotherapy protocols: High Dose Arm, Low Dose Arm, or Cooked/Transformed Allergen Arm. Dose progression and form of allergen vary by assigned protocol.
Trial Site Locations
Total: 1 location
1
Research Institute of the McGill University Health Centre
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
Research Team
D
Duncan Lejtenyi, M.Sc
L
Liane Beaudette, RN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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