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Search / Trial NCT05923216

Induction of Sustained Unresponsiveness to Sesame Using High- and Low-dose Sesame Oral Immunotherapy

Launched by MEDICAL UNIVERSITY OF WARSAW · Jun 19, 2023

Trial Information

Current as of July 22, 2025

Enrolling by invitation

Keywords

Sesame Food Allergy Sustained Unresponsiveness Children

ClinConnect Summary

Oral immunotherapy is considered the most effective treatment for food allergy. There are two main goals of food immunotherapy: achievement of desensitisation and sustained unresponsiveness.

Desensitisation involves achieving temporary tolerance of the allergenic food by the patient only during regular intake of the allergen. The most desirable effect of immunotherapy is to achieve sustained unresponsiveness, i.e. to maintain the absence of adverse symptoms to a given allergen after specific immunotherapy has been discontinued for a defined period of time.

The study is a continuation of a...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • patients who have accomplished their per-protocol participation in trial NCT05158413.
  • signed Informed Consent by parent/legal guardian and patient aged\>16 years old
  • patient's/caregiver's cooperation with researcher
  • Exclusion Criteria:
  • severe asthma
  • uncontrolled mild/moderate asthma: forced expiratory volume at one second (FEV1)\<80% (under 5 percentile), FEV1/forced vital capacity (FEV)\<75% (under 5 percentile), hospitalization due to asthma exacerbation within last 12 months
  • current oral/sublingual/subcutaneous immunotherapy with another allergen
  • eosinophilic esophagitis
  • allergic reaction of 4th or higher grade according to the World Allergy Organisation Systemic Allergic Reaction Grading System during immunotherapy
  • a history of severe recurrent anaphylaxis episodes
  • chronic diseases requiring continous treatment, including heart disease, epilepsy, metabolic disease, diabetes
  • * medication:
  • oral, daily steroid therapy exceeding 1 month within the last 12 months
  • at least two courses of oral steroid therapy (at least 7 days) within the last 12 months
  • oral steroid therapy longer than 7 days within the last 3 months
  • biological treatment
  • the need to constantly take antihistamines
  • therapy with b-blockers, angiotensin converting enzyme (ACE) inhibitors, calcium channel inhibitors
  • pregnancy
  • no consent to participate in the study
  • lack of patient cooperation

About Medical University Of Warsaw

The Medical University of Warsaw is a leading academic institution dedicated to advancing healthcare through innovative research and education. Renowned for its commitment to excellence in medical training and clinical practice, the university actively engages in a diverse range of clinical trials aimed at improving patient outcomes and enhancing medical knowledge. With a robust infrastructure and a multidisciplinary team of experts, the Medical University of Warsaw fosters collaboration in the development of novel therapies and interventions, contributing significantly to the global medical research landscape.

Locations

Warsaw, , Poland

Patients applied

0 patients applied

Trial Officials

Katarzyna Grzela, PhD, MD

Study Chair

Medical University of Warsaw

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported