Investigating Modified Protocols of Oral Immunotherapy to Validate Efficacy and Safety

Overview

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.

Interventions

• 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 m

Primary outcome measures

• Rate of anaphylaxis in different Oral Immunotherapy protocols [Time frame: 3 years]

Secondary outcome measures (1)

• Efficacy of different Oral Immunotherapy protocols [Time frame: 3 years]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Canada · 1 center

• Research Institute of the McGill University Health Centre — Montreal

Identifiers

NCT: NCT06256146 · 2022-8424

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗