Efficacy and Safety of Low-dose Sesame Oral Immunotherapy in Pediatric Patients
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.
- EligibilityCriteria: 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 β-blockers, angiotensin-converting enzyme (ACE) inhibitors, calcium channel inhibitors, Pregnancy, No consent to participate in the study, Lack of patient or caregiver cooperation. - HealthyVolunteers: No - Gender: All - MinimumAge: 3 Years - MaximumAge: 17 Years - StdAgeList: Child