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Oral Immunotherapy in Young Children With Food Allergy

NCT05738798 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2025-09-16

No results posted yet for this study

Summary

The goal of this clinical trial is to learn about oral immunotherapy in food allergic children \< 30 months of age. The main question it aims to answer is: What is the clinical- and cost-effectiveness of early low-dose oral immunotherapy aimed at long-term tolerance induction. Participants will receive oral immunotherapy for 1 year with a maintenance dose of 300 mg allergenic protein and are compared with food allergic infants not receiving oral immunotherapy to compare with natural tolerance development.

Conditions

Interventions

DIETARY_SUPPLEMENT

oral immunotherapy

oral immunotherapy is performed by freely available, widely used food products, regularly part of a normal infant's diet such as peanut butter or boiled egg.

Sponsors & Collaborators

  • Dutch National Health Care Institute

    collaborator OTHER

  • University of Twente

    collaborator OTHER

  • Utrecht University

    collaborator OTHER

  • Deventer Ziekenhuis

    lead OTHER

Principal Investigators

  • Ted Klok, MD PhD · Deventer Ziekenhuis

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
9 Months
Max Age
30 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-01
Primary Completion
2026-08-30
Completion
2027-05-01

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

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 NCT05738798 on ClinicalTrials.gov