Oral immunotherapy using cashew protein for children with cashew allergy

Efficacy of Cashew Nut Protein Immunotherapy

This study is testing if giving cashew protein to children with a cashew allergy can help them tolerate cashews better instead of just avoiding them.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 39 (estimated)
• Ages: 4 Years to 17 Years
• Sex: All
• Sponsor: Medical University of Warsaw (Academic / other)
• Drugs / interventions: immunotherapy
• Locations: 1 site (Warsaw, Masovian Voivodeship)
• Trial ID: NCT06328504 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are children aged 4 to 17 years with a confirmed IgE-mediated allergy to cashew.

Not a fit: Patients without a confirmed allergy to cashew or those with poorly controlled asthma may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve the quality of life for children with cashew allergies by reducing their allergic reactions.

How similar studies have performed: Other studies have shown promise with similar immunotherapy approaches for food allergies, indicating potential for success in this trial.

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.

Where this trial is running

Warsaw, Masovian Voivodeship

• 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

Conditions Food Allergy; cashew; food allergy; immunotherapy; children