High and Low Dose Oral Peanut Immunotherapy - Comparison of Efficacy and Safety

Launched by MEDICAL UNIVERSITY OF WARSAW · Jun 2, 2020

Keywords

ClinConnect Summary

This clinical trial is looking at how effective and safe it is to give children with peanut allergies different doses of peanut protein to help them build tolerance. Researchers are comparing a higher dose of 300 mg to a lower dose of 150 mg. The goal is to see if either dose works better in reducing allergic reactions to peanuts.

To be part of this study, children must have a confirmed peanut allergy, meaning they have had a reaction to peanuts in the past and have tested positive for the allergy through skin tests or blood tests. They should be between 4 and 17 years old and have been able to handle less than 100 mg of peanut protein in a food challenge. If chosen, participants will receive either the higher or lower dose of peanut protein over time, and their health will be monitored closely. It’s important to know that this trial is not for everyone; those with severe asthma, certain medical conditions, or who are currently on specific medications may not be eligible to participate.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.