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Specific Oral Tolerance Induction (SOTI) to Children With IgE-mediated Wheat Allergy

NCT03352193 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 15

Last updated 2024-07-30

No results posted yet for this study

Summary

This is an observational pilot study investigating the effectiveness, safety and specific immunological mechanisms of Specific Oral Tolerance Induction (SOTI) in children with IgE-mediated wheat allergy.

The study will include 10 patients with persistent IgE-mediated allergy to wheat, who will undergo 1-year home SOTI. Moreover, 5 patients with IgE-mediated allergy to wheat will be followed for 1-year period after their diagnosis, without any intervention.

Well-cooked wheat spaghetti will be given daily to patients with a programmed weekly dose increment for 27 weeks (up-dosing phase).

Subsequently, wheat protein maintenance dose will be received daily for additional 6 months (maintenance phase), while afterwards patients will be clinically assessed and a 2nd OFC at a higher cumulative dose of wheat protein will be performed, in order to assess patients' desensitization to wheat.

Skin Prick Tests (SPTs) to wheat, blood sampling for the determination of total IgE, wheat specific IgEs and wheat Basophil Activation Test (BAT) will be performed at baseline, when patients reach the maintenance dose and before the 2nd OFC.

Regarding historical control group the same testing will be performed at baseline and at re-evaluation (post 12 months).

Conditions

  • Wheat Allergy

Interventions

DIETARY_SUPPLEMENT

Wheat spaghetti

Wheat oral immunotherapy

Sponsors & Collaborators

  • Athens General Children's Hospital "Pan. & Aglaia Kyriakou"

    lead OTHER

Principal Investigators

  • Nikolaos Kitsioulis, MD · National and Kapodistrian University of Athens

  • Nikolaos Papadopoulos, MD, PhD · National and Kapodistrian University of Athens

Eligibility

Min Age
2 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-08
Primary Completion
2025-10-31
Completion
2025-10-10

Countries

  • Greece

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 NCT03352193 on ClinicalTrials.gov