NCT06256146

Investigating Modified Protocols of Oral Immunotherapy to Validate Efficacy and Safety

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 360 (estimated)
• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre · Academic / Other
• Sex: All
• Age: 2 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Peanut Allergy
• Milk Allergy, Cow's
• Egg Allergy

Interventions

Type	Name	Description
OTHER	Food allergy desensitization / Oral Immunotherapy	Participants consume increasing doses of allergenic food daily until they reach a maintenance dose. In the case of the High Dose Arm, participants will progress to a daily dose of either 1200 mg, 300 mg or 200 ml of egg, peanut or milk respectively. Participants randomized to the Low Dose Arm also begin by consuming small amounts of the allergenic food, gradually increasing the daily dose. However, participants in this group only progress to 300 ml, 30 mg or 50 ml daily dose of egg, peanut or milk respectively. The Cooked/Transformed Allergen Arm begins the desensitization with a cooked or transformed form of the allergen - muffins in the case of egg or milk, Bamba puffs in the case of peanut. Participants take increasing amounts of these products (one muffin for egg and milk and four Bamba puffs for peanut) then transition to egg, milk or peanut. Participants then continue their dose progression, getting to 1200 mg, 200 ml or 300 mg for egg, milk and peanut respectively.

Timeline

• Start date: 2022-03-01
• Primary completion: 2030-02-28
• Completion: 2030-02-28
• First posted: 2024-02-13
• Last updated: 2026-02-09

Locations

1 site across 1 country: Canada