Clinical Trial

Multi-Food Oral Immunotherapy for Peanut and Tree Nuts

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Summary
This study aims to evaluate the efficacy and safety of multi-food oral immunotherapy (multi-OIT) using peanut and tree nuts proteins in children with confirmed food allergy to at least two allergens. Participants will be randomized in a 2:1 ratio to receive either multi-OIT or standard management consisting of an elimination diet. The primary objective is to evaluate immunotherapy efficacy defined as achieving tolerance to a cumulative dose of 4444 mg of protein during an oral food challenge (OFC-2) for at least one allergen that elicited a reaction during baseline challenge (OFC-1), compared with the control group. Secondary outcomes include the proportion of participants tolerating multiple allergens at the target cumulative dose; the incidence, type, and severity of adverse events classified according to the World Allergy Organization (WAO) grading system; changes in immunological parameters, including allergen-specific IgE and IgG4 levels; changes in skin prick test responses; changes in the quality of life of patients and their families.
Trial Details
NCT Number NCT07764159
Lead Sponsor Medical University of Warsaw
Conditions Food Allergies, Food Allergy in Children, Peanut Allergies, Tree Nut Allergies, Oral Immunotherapy for Food Allergy
Enrollment 39 participants
Start Date 2026-09
Primary Completion 2031-09 (estimated)
Study Completion 2031-12 (estimated)
Updated on ClinicalTrials.gov 2026-08-13