Efficacy of Cashew Nut Protein Immunotherapy

Cashew Protocol

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

2024-03-01

2026-04-21

2027-04-21

Not yet recruiting

39

Inclusion Criteria: * age between 4 and 17 years, * IgE-mediated cashew allergy confirmed with positive skin prick tests with cashew 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 cashew 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 allergy to cashew, * negative provocation test with cashew, * severe asthma, * mild/moderate asthma poorly controlled: FEV1\<80% (less than 5 perc), FEV1/FVC\<75% (less than 5 perc), hospitalization for asthma exacerbation in the past 12 months, * oral/sublingual/subcutaneous immunotherapy to other allergens during the study, * eosinophilic gastroenteritis, * chronic diseases requiring ongoing treatment, including heart disease, epilepsy, metabolic diseases, diabetes, * taking medications: * oral, daily steroid therapy \>1 month in the past 12 months, * a minimum of 2 times oral steroid therapy (a period of at least 7 days) in the past 12 months, * one-time oral steroid therapy (min. 7 days) in the last 3 months, * biological treatment, * need to take antihistamines continuously, * therapy with β-blockers, ACE-inhibitors, calcium channel inhibitors, * pregnancy, * lack of consent to participate in the study, * lack of patient cooperation.

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 39, 'type': 'ESTIMATED'}}

2024-03-25