Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:12 AM
Ignite Modification Date:
2025-12-25 @ 1:12 AM
NCT ID:
NCT04415593
Eligibility Criteria:
Inclusion Criteria:
* medical history of peanut allergy,
* IgE-mediated peanut allergy confirmed as positive skin prick tests with peanut 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) (UniCAP method),
* reaction to less than 100 mg of peanut protein during OOFC,
* signed Informed Consent by parent/legal guardian and patient aged \>16 years old,
* patient's/caregivers' cooperation with researcher.
Exclusion Criteria:
* no confirmed peanut allergy,
* negative oral food challenge with less than 100mg of peanut protein,
* 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 allergen,
* 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 last 12 months,
* at least two courses of oral steroid therapy (at least 7 days) within last 12 months,
* oral steroid therapy longer than 7 days within last 3 months,
* biological treatment,
* the need to constantly take antihistamines,
* therapy with β-blockers, angiotensin converting enzyme (ACE) inhibitors, calcium channel inhibitors,
* pregnancy,
* no consent to participate in the study,
* lack of patient cooperation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
17 Years
Study:
NCT04415593
Study Brief:
Protocol Section:
NCT04415593