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Multi-Food Oral Immunotherapy for Peanut and Tree Nuts

NCT07764159 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2026-08-13

No results posted yet for this study

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.

Conditions

  • Food Allergies
  • Food Allergy in Children
  • Peanut Allergies
  • Tree Nut Allergies
  • Oral Immunotherapy for Food Allergy

Interventions

OTHER

Multi-Food Oral Immunotherapy (Multi-OIT) with Peanut and Tree Nuts Proteins

Multi-food oral immunotherapy using a standardized mixture of peanut and tree nuts proteins (cashew, walnut, hazelnut, and almond), administered in a dose-escalation phase followed by a maintenance phase with a target daily dose of 300 mg of protein per allergen.

OTHER

Standard of Care (Elimination Diet)

Standard management consisting of strict dietary avoidance of peanut and tree nuts, along with the use of rescue medications, including epinephrine, in the event of accidental allergen exposure.

Sponsors & Collaborators

  • Medical University of Warsaw

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2031-09-30
Completion
2031-12-31

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07764159 on ClinicalTrials.gov