Oral immunotherapy using cashew protein for children with cashew allergy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of oral immunotherapy with cashew protein in children aged 4 to 17 years who have a confirmed IgE-dependent allergy to cashew. Participants will be randomly assigned to receive either a maintenance dose of cashew protein or standard treatment involving avoidance of cashew consumption. The study aims to determine if this immunotherapy can provide a safe alternative to allergen avoidance strategies. The trial will follow established guidelines for food allergy immunotherapy and will monitor participants closely during the desensitization process.

Why it matters

Who can join: the full rules

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.

Where it's running

• Medical University of Warsaw
  Warsaw, Masovian Voivodeship, Poland Recruiting

Study contacts

• Principal investigator: Agnieszka Szczukocka-Zych, MD — Medical University of Warsaw
• Study coordinator: Katarzyna Grzela, PhD, MD
• Email: katarzyna.grzela@wum.edu.pl
• Phone: +48223179431

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.