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Comparing Standard and Autoclaved Peanut Oral Immunotherapy in People With Peanut Allergy

StatusNot Yet Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Re-verified, no change to tracked fieldsv2
  2. Minor Study First Submitted
Peanut allergy can cause serious and potentially life-threatening allergic reactions. Oral immunotherapy (OIT) is an investigational treatment that involves giving small, gradually increasing amounts of peanut protein to help reduce allergic sensitivity. However, OIT may cause allergic reactions during treatment. This Phase II clinical trial will compare two forms of peanut used for oral immunotherapy: standard blanched peanuts and autoclaved peanuts (peanuts heated under high temperature and pressure to modify their proteins). Participants aged 4 to 30 years with confirmed peanut allergy will be randomly assigned to receive one of the two treatments. The study will evaluate safety, tolerability, adherence, and the ability to tolerate a higher amount of peanut protein after 12 months of therapy. The goal is to determine whether autoclaved peanuts provide a safer and better tolerated approach to peanut oral immunotherapy.
Trial Details
NCT Number NCT07439406
Lead Sponsor McGill University Health Centre/Research Institute of the McGill University Health Centre
Conditions
(from sponsor)
Peanut Allergy
Related terms Peanut Hypersensitivity
Enrollment 57 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov