Status:
NOT_YET_RECRUITING
Sustained Unresponsiveness (SU) to Cashew Nut Protein Following Oral Allergen-Specific Immunotherapy
Lead Sponsor:
Medical University of Warsaw
Conditions:
Food Allergy in Children
Eligibility:
All Genders
4-17 years
Phase:
NA
Brief Summary
This study is a long-term follow-up of participants from the randomized controlled trial (RCT) "Efficacy of Cashew Nut Protein Immunotherapy: A Protocol of a Single-Center Randomized Controlled Trial ...
Detailed Description
Oral immunotherapy (OIT) is currently recognized as the most effective disease-modifying intervention for IgE-mediated food allergies. The therapeutic objectives of OIT encompass two distinct immunolo...
Eligibility Criteria
Inclusion
- Cashew nut allergy confirmed prior to the initiation of immunotherapy
- Completion of the first phase of the study, including achievement of the maintenance dose (1200 mg of cashew nut protein) during immunotherapy
- Provision of informed consent for participation in the study
- Adequate cooperation from the patient and/or their legal guardians
Exclusion
- Severe asthma
- Poorly controlled mild-to-moderate asthma, defined as:
- FEV1 \< 80% (below the 5th percentile),
- FEV1/FVC ratio \< 75% (below the 5th percentile),
- Hospitalization due to asthma exacerbation within the past 12 months
- Oral, sublingual, or subcutaneous immunotherapy for other allergens during the first year/season of therapy
- Eosinophilic gastrointestinal disorders
- Severe, recurrent episodes of anaphylaxis within the last 6 months
- Chronic illnesses requiring ongoing treatment, including:
- Cardiac conditions
- Epilepsy
- Metabolic disorders
- Diabetes mellitus
- Use of the following medications:
- Daily oral corticosteroid therapy \>1 month within the past 12 months
- At least two courses of oral corticosteroids (minimum duration of 7 days each) in the past 12 months
- One course of oral corticosteroids (minimum 7 days) within the past 3 months
- Biologic therapies
- Treatment with β-blockers, ACE inhibitors, or calcium channel blockers
- Pregnancy
- Lack of informed consent for participation
- Lack of cooperation from the patient
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2029
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT07158619
Start Date
September 1 2025
End Date
May 1 2029
Last Update
September 8 2025
Active Locations (1)
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1
Medical University of Warsaw
Warsaw, Masovian Voivodeship, Poland, 02-091