NCT06328504 Efficacy of Cashew Nut Protein Immunotherapy
| NCT ID | NCT06328504 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical University of Warsaw |
| Condition | Food Allergy |
| Study Type | INTERVENTIONAL |
| Enrollment | 39 participants |
| Start Date | 2024-03-28 |
| Primary Completion | 2026-04-21 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 39 participants in total. It began in 2024-03-28 with a primary completion date of 2026-04-21.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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, ACE-inhibitors (angiotensin converting enzyme), calcium channel inhibitors, * pregnancy, * lack of consent to participate in the study, * lack of patient cooperation.
Contact & Investigator
Agnieszka Szczukocka-Zych, MD
PRINCIPAL INVESTIGATOR
Medical University of Warsaw
Frequently Asked Questions
Who can join the NCT06328504 clinical trial?
This trial is open to participants of all sexes, aged 4 Years or older, up to 17 Years, studying Food Allergy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06328504 currently recruiting?
Yes, NCT06328504 is actively recruiting participants. Contact the research team at katarzyna.grzela@wum.edu.pl for enrollment information.
Where is the NCT06328504 trial being conducted?
This trial is being conducted at Warsaw, Poland.
Who is sponsoring the NCT06328504 clinical trial?
NCT06328504 is sponsored by Medical University of Warsaw. The principal investigator is Agnieszka Szczukocka-Zych, MD at Medical University of Warsaw. The trial plans to enroll 39 participants.