Investigating Modified Protocols of Oral Immunotherapy to Validate Efficacy and Safety

Launched by MCGILL UNIVERSITY HEALTH CENTRE/RESEARCH INSTITUTE OF THE MCGILL UNIVERSITY HEALTH CENTRE · Feb 9, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating new ways to help people with food allergies, specifically to peanuts, milk, eggs, and cow's milk. The goal is to see if using lower doses of the allergenic food or processed versions of these foods can help patients gradually become less sensitive to them, while also reducing the chances of having allergic reactions during the treatment process. This kind of treatment, known as Oral Immunotherapy (OIT), has shown promise in other countries, but some doctors and patients are hesitant to try it due to concerns about safety.

To participate in the trial, individuals typically need to have a history of allergic reactions to one of the foods being studied, along with specific allergy test results that confirm the allergy. However, certain people will not be eligible, such as those with uncontrolled asthma or specific heart conditions. If you or a loved one qualifies for this trial, participants can expect to receive careful monitoring and support throughout the treatment process. This research aims to make food allergy treatments safer and more effective for everyone affected.

Gender

ALL

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).