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
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).
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06328504
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