Status:
COMPLETED
High and Low Dose Oral Peanut Immunotherapy - Comparison of Efficacy and Safety
Lead Sponsor:
Medical University of Warsaw
Conditions:
Peanut Allergy
Eligibility:
All Genders
4-17 years
Phase:
NA
Brief Summary
In this trial the investigators aim to assess the effectiveness and safety of oral immunotherapy with peanut protein in high and low dose (300mg versus 150mg) in children with peanuts allergy.
Detailed Description
Peanut allergy is a significant clinical problem. Food immunotherapy provides the latest approach to managing food allergy. Oral immunotherapy is considered as the most effective and safe, according t...
Eligibility Criteria
Inclusion
- medical history of peanut allergy,
- IgE-mediated peanut allergy confirmed as positive skin prick tests with peanut allergens (diameter of the wheal greater than 3mm) and/or specific IgE level greater than 0.35 kilo units of Allergen per liter (kUA/l) (UniCAP method),
- reaction to less than 100 mg of peanut protein during OOFC,
- signed Informed Consent by parent/legal guardian and patient aged \>16 years old,
- patient's/caregivers' cooperation with researcher.
Exclusion
- no confirmed peanut allergy,
- negative oral food challenge with less than 100mg of peanut protein,
- severe asthma,
- uncontrolled mild/moderate asthma: forced expiratory volume at one second (FEV1)\<80% (under 5. percentile), FEV1/forced vital capacity (FVC)\<75% (under 5. percentile), hospitalization due to asthma exacerbation within last 12 months,
- current oral/sublingual/subcutaneous immunotherapy with other allergen,
- eosinophilic gastroenteritis,
- a history of severe recurrent anaphylaxis episodes,
- chronic diseases requiring continuous treatment, including heart disease, epilepsy, metabolic diseases, diabetes,
- medication:
- oral, daily steroid therapy longer than 1 month within last 12 months,
- at least two courses of oral steroid therapy (at least 7 days) within last 12 months,
- oral steroid therapy longer than 7 days within last 3 months,
- biological treatment,
- the need to constantly take antihistamines,
- therapy with β-blockers, angiotensin converting enzyme (ACE) inhibitors, calcium channel inhibitors,
- pregnancy,
- no consent to participate in the study,
- lack of patient cooperation.
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2024
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT04415593
Start Date
September 1 2020
End Date
July 30 2024
Last Update
December 8 2025
Active Locations (1)
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1
Department of Pediatric Pneumonology and Allergy, Medical University of Warsaw
Warsaw, Poland, 02-091