An interventional study of Food allergy desensitization / Oral Immunotherapy in Peanut Allergy, Milk Allergy, Cow's and Egg Allergy, sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre. Recruiting at 1 site in Canada. Open to participants aged 2 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-05-07.
Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre · Not applicable, Interventional, and Treatment
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.
166 studies on the registry are indexed under Peanut Hypersensitivity; 27 are open to participants now.
This study's planned enrollment of 360 is above the median of 50 across 127 interventional studies indexed under Peanut Hypersensitivity.
Browse Peanut Hypersensitivity studies →McGill University Health Centre/Research Institute of the McGill University Health Centre is the lead sponsor of 421 studies on the registry; 105 are open to participants now.
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The presence of at least one of the following confirmatory tests:
Exclusion Criteria:
Subjects will progress through desensitization to a high maintenance dose - 1200 mg of crushed peanut, 200 ml of milk or 1200 mg of egg powder.
Other: Food allergy desensitization / Oral Immunotherapy
Subjects will progress through desensitization to a low maintenance dose - 120 mg of crushed peanut, 50 ml of milk or 300 mg of egg powder.
Other: Food allergy desensitization / Oral Immunotherapy
Subjects will begin desensitization with cooked versions of the allergen (muffins in the case of egg and milk) or transformed versions (Bamba puffs for peanut). They will progress up to a full muffin or 4 Bamba puffs (for egg/milk and peanut respectively). Once subjects have reached these doses, they will transition to doses of pure allergen. They will then progress to the same top dose as subjects in the High Dose Arm.
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.
Rate of anaphylaxis in different Oral Immunotherapy protocols
Do participants in the different study arms experience similar rates of anaphylaxis during their participation in the study? Anaphylaxis is defined as an allergic reaction to the food the subject is allergic to, that involves symptoms in two of the following organ systems: skin, respitratory, gastro-enterologic or neurologic.The Consortium for Food Allergy Research (CoFAR) grading scale will be used for assessing severuty of allergic symptoms
Time frame: 3 years
Efficacy of different Oral Immunotherapy protocols
Do participants in the three study arms experience similar levels of desensitization to their allergen? This will be assessed by a Double-Blind Placebo Controlled Oral Food Challenge (DBPCFC). Doses of allergen that elicit symptoms strong enough to end the challenge will be compared between the three groups. Symptom severity will be graded using the CoFAR grading scale.
Time frame: 3 years
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — No IPD will be shared. All participant data will remain strictly confidential
Started Mar 2022 (actual). Primary completion is estimated for Feb 2030, 95 months after the start.
Of 20 interventional studies with no phase under Peanut Hypersensitivity, half reached primary completion within 62 months of starting (the median), counting those still running; a quarter within 31 and three quarters within 66. This study's planned 95 months is above that.
How these figures are worked out, and which studies are left out of them.
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McGill University Health Centre/Research Institute of the McGill University Health Centre →