Efficacy of Cashew Nut Protein Immunotherapy (NCT06328504) | Clinical Trial Compass
RecruitingNot Applicable
Efficacy of Cashew Nut Protein Immunotherapy
Poland39 participantsStarted 2024-03-28
Plain-language summary
It is a randomized, single-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.
Who can participate
Age range4 Years – 17 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* age between 4 and 17 years,
* IgE (immunoglobulin E) -mediated cashew allergy confirmed with positive skin prick tests with cashew allergens (diameter of the wheal greater than 3mm) and/or specific IgE (immunoglobulin E) 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 (forced expiratory volume at one second) \<80% (less than 5 perc), FEV1/FVC (forced expiratory volume at one second/forced vital capacity) \<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,…
What they're measuring
1
Cashew full tolerance
Timeframe: Up to 60 weeks of OIT (oral immunotherapy)