Actively Recruiting

Phase Not Applicable
Age: 4Years - 17Years
All Genders
NCT06328504

Efficacy of Cashew Nut Protein Immunotherapy

Led by Medical University of Warsaw · Updated on 2025-01-30

39

Participants Needed

1

Research Sites

159 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Efficacy of Cashew Nut Protein Immunotherapy

Who Can Participate

Age: 4Years - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 4 and 17 years
  • Confirmed IgE-mediated cashew allergy with positive skin prick test or specific IgE level >0.35 kUA/l
  • Allergic reaction to cashew protein during oral food challenge
  • Signed informed consent by parent/legal guardian and patient if older than 16 years
  • Cooperation by patient and caregivers with the research team
Not Eligible

You will not qualify if you...

  • No confirmed allergy to cashew
  • Negative provocation test with cashew
  • Severe asthma or poorly controlled mild/moderate asthma (FEV1 <80%, FEV1/FVC <75%, or recent hospitalization for asthma)
  • Receiving oral, sublingual, or subcutaneous immunotherapy to other allergens during the study
  • Eosinophilic gastroenteritis
  • Chronic diseases requiring ongoing treatment such as heart disease, epilepsy, metabolic diseases, diabetes
  • Use of oral steroids for more than 1 month in the past year, or multiple steroid courses in the past year, or recent steroid use within 3 months
  • Biological treatment
  • Continuous need for antihistamines
  • Therapy with beta-blockers, ACE inhibitors, or calcium channel blockers
  • Pregnancy
  • Lack of consent or cooperation with study requirements

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Medical University of Warsaw

Warsaw, Masovian Voivodeship, Poland, 02-091

Actively Recruiting

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Research Team

K

Katarzyna Grzela, PhD, MD

CONTACT

A

Agnieszka Szczukocka-Zych, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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