Efficacy of Cashew Nut Protein Immunotherapy

Launched by MEDICAL UNIVERSITY OF WARSAW · Mar 22, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for children with cashew allergies. Researchers want to see if giving cashew nut protein in a controlled way (called oral immunotherapy) can help children tolerate cashews better compared to the usual treatment, which is to simply avoid eating cashews. The trial is open to children aged 4 to 17 years who have a confirmed allergy to cashews, demonstrated by specific allergy tests and past allergic reactions.

If your child is eligible and decides to join the study, they will receive either the cashew protein treatment or standard care while being closely monitored by the research team. It's essential that families are willing to cooperate with the study's requirements and that children do not have certain other health issues that could complicate their participation, such as severe asthma or other ongoing medical treatments. Overall, this trial could provide valuable information on a potential new approach to managing cashew allergies in children.

Gender

ALL

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.