NCT06256146 Investigating Modified Protocols of Oral Immunotherapy to Validate Efficacy and Safety
| NCT ID | NCT06256146 |
| Status | Recruiting |
| Phase | — |
| Sponsor | McGill University Health Centre/Research Institute of the McGill University Health Centre |
| Condition | Peanut Allergy |
| Study Type | INTERVENTIONAL |
| Enrollment | 360 participants |
| Start Date | 2022-03-01 |
| Primary Completion | 2030-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 360 participants in total. It began in 2022-03-01 with a primary completion date of 2030-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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).
Contact & Investigator
Moshe Ben-Shoshan, MD
PRINCIPAL INVESTIGATOR
MUHC-RI
Frequently Asked Questions
Who can join the NCT06256146 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 40 Years, studying Peanut Allergy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06256146 currently recruiting?
Yes, NCT06256146 is actively recruiting participants. Contact the research team at duncan.lejtenyi@muhc.mcgill.ca for enrollment information.
Where is the NCT06256146 trial being conducted?
This trial is being conducted at Montreal, Canada.
Who is sponsoring the NCT06256146 clinical trial?
NCT06256146 is sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre. The principal investigator is Moshe Ben-Shoshan, MD at MUHC-RI. The trial plans to enroll 360 participants.