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โ† Trials
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Efficacy and Safety of Low-dose Sesame Oral Immunotherapy in Pediatric Patients

RecruitingNAAges 3 Years - 17 YearsAllMedical University of Warsaw
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In plain words

What the trial is, and whether it could suit you

It is a randomized, single-center, controlled trial to evaluate the effectiveness of oral immunotherapy with low-dose sesame protein compared with standard treatment (elimination diet) in patients with sesame allergy.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age between 3 and 17 years, * IgE-mediated sesame allergy confirmed with positive skin prick tests with sesame allergens (diameter of the wheal greater than 3mm) and/or specific IgE level greater than 0.35-kilo units of Allergen per liter (kUA/l), * Allergic reaction to sesame protein during oral food challenge (OFC), * Signed Informed Consent by parent/legal guardian and patient aged \>16 years old, * Patient's and caregivers' cooperation with the researcher. Exclusion Criteria: * No confirmed sesame allergy, * Negative OFC with sesame protein (maximum dose 4000mg), * Severe asthma, uncontrolled mild/moderate asthma: forced expiratory volume at one second (FEV1)\<80% (under 5. percentile), FEV1/forced vital capacity (FVC)\<75% (under 5. percentile), hospitalization due to asthma exacerbation within last 12 months, * Current oral/sublingual/subcutaneous immunotherapy with other allergens in the first year of immunotherapy, * Eosinophilic gastroenteritis, * A history of severe recurrent anaphylaxis episodes, * Chronic diseases requiring continuous treatment, including heart disease, epilepsy, metabolic diseases, diabetes, * Medication: * oral, daily steroid therapy longer than 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, * any biological treatment, * therapy with ฮฒ-blockers, angiotensin-converting enzyme (ACE) inhibitors, calcium channel inhibitors, * Pregnancy, * No consent to participate in the study, * Lack of patient or caregiver cooperation.
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What it tests

  • Dietary Supplement: Low dose OIT
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Where

1 site
Medical University of Warsaw
Warsaw, Poland
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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