๐ฌIn 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.
๐ 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.