Investigating new methods for oral immunotherapy in food allergies

Investigating Modified Protocols of Oral Immunotherapy to Validate Efficacy and Safety

This study is testing new ways to use oral immunotherapy to help people with food allergies, like those to peanuts and milk, feel safer and have fewer allergic reactions during treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 360 (estimated)
• Ages: 2 Years to 40 Years
• Sex: All
• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre (Academic / other)
• Drugs / interventions: Immunotherapy
• Locations: 1 site (Montreal, Quebec)
• Trial ID: NCT06256146 on ClinicalTrials.gov

What this trial studies

This study explores modified protocols for oral immunotherapy (OIT) aimed at treating common food allergies, including peanut, milk, cow's, and egg allergies. It seeks to determine if using low doses or processed versions of allergens can effectively desensitize patients while minimizing allergic reactions during treatment. The study will involve patients with a history of immediate allergic reactions to specific foods and will utilize established diagnostic tests to confirm eligibility. By addressing concerns about safety and efficacy, this research aims to enhance the acceptance of OIT in clinical practice.

Who should consider this trial

Good fit: Ideal candidates are individuals with a documented history of immediate allergic reactions to specific food allergens and positive diagnostic tests confirming their allergies.

Not a fit: Patients with uncontrolled respiratory diseases or other active intercurrent diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a safer and more effective treatment option for patients with food allergies.

How similar studies have performed: Other studies have shown promise in using modified oral immunotherapy protocols, but this specific approach is being investigated for the first time.

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).

Where this trial is running

Montreal, Quebec

• Research Institute of the McGill University Health Centre — Montreal, Quebec, Canada (Recruiting)

Study contacts

• Principal investigator: Moshe Ben-Shoshan, MD — Muhc-Ri
• Study coordinator: Duncan Lejtenyi, M.Sc

Conditions Peanut Allergy; Milk Allergy, Cow's; Egg Allergy