Investigating Modified Protocols of Oral Immunotherapy to Validate Efficacy and Safety

Not Applicable

Recruiting

• Conditions: Peanut Allergy; Egg Allergy; Milk Allergy, Cow's
• Interventions: Other: Food allergy desensitization / Oral Immunotherapy

• Registration Number: NCT06256146
• Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-01
• Study First Submitted: 2023-07-06
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-09
• Last Update Submitted: 2024-02-12
• Study First Posted: 2024-02-13
• Last Update Posted: 2024-02-14
• Primary Completion: 2030-02-28
• Study Completion: 2030-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

• A history suggestive of immediate allergy to the food. A convincing clinical history of an IgE mediated reaction to a specific food will be defined as a minimum of 2 mild signs/symptoms or 1 moderate or 1 severe sign/symptom that was likely IgE mediated and occurred 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 of the normal saline control). The allergens used will be commercial extracts of the foods (Omega Labs, Toronto, Ontario).
  • Detection of serum specific IgE (>0.35 kU/L) to the culprit food or any of its proteins, measured by fluorescence enzyme immunoassay (Phadia, CAP System, Uppsala, Sweden).

Exclusion Criteria

• Patients who have uncontrolled respiratory disease (asthma, cystic fibrosis, etc.)
• Patients who present with intercurrent disease active 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.
• Patients receiving oral immunosuppressor therapy.
• Patients receiving β-blockers (including topical formulations), or who receive daily doses 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 patients with a history of antacid use for reflux related to food impaction or with a history of esophageal spasm.
• Patients already tolerating processed/cooked forms of the food (e.g.,baked goods with milk).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Protocol - High Dose Arm	Food allergy desensitization / Oral Immunotherapy	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.
Modified Protocol - Low Dose Arm	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.
Modified Protocol - Cooked/Transformed Allergen Arm	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.

Primary Outcome Measures

Name	Time	Method
Rate of anaphylaxis in different Oral Immunotherapy protocols	3 years	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

Secondary Outcome Measures

Name	Time	Method
Efficacy of different Oral Immunotherapy protocols	3 years	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.

Trial Locations

Locations (1)

Research Institute of the McGill University Health Centre; 🇨🇦 Montreal, Quebec, Canada