RecruitingNot ApplicableNCT06328504

Efficacy of Cashew Nut Protein Immunotherapy

Sponsor

Medical University of Warsaw

Enrollment

39 participants

Start Date

Mar 28, 2024

Study Type

INTERVENTIONAL

Conditions

Food allergy

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.

Eligibility

Min Age: 4 YearsMax Age: 17 Years

Inclusion Criteria5

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 Criteria17

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, ACE-inhibitors (angiotensin converting enzyme), calcium channel inhibitors,
pregnancy,
lack of consent to participate in the study,
lack of patient cooperation.

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Interventions

COMBINATION_PRODUCTCashew immunotherapy

Following the building-up phase (up to 60 weeks), patients will receive a daily low dose of cashew flour (1200 mg cashew protein) mixed with well-tolerated fruit mousse for 3 months (12 +/- 3 weeks).