Comparing high and low doses of oral peanut immunotherapy for children with peanut allergies
High and Low Dose Oral Peanut Immunotherapy - Comparison of Efficacy and Safety
This study tests whether giving children with peanut allergies a high or low dose of peanut protein can help them build tolerance to peanuts and manage their allergies better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 4 Years to 17 Years |
| Sex | All |
| Sponsor | Medical University of Warsaw Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Warsaw) |
| Trial ID | NCT04415593 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness and safety of oral immunotherapy using peanut protein at two different doses (300mg and 150mg) in children diagnosed with peanut allergies. Participants will undergo an open oral food challenge to confirm their allergy before being randomly assigned to receive either a high or low dose of peanut protein. The treatment involves gradually increasing the dose of ground roasted peanuts during hospitalization, followed by a maintenance phase where the dose is sustained for two months. The goal is to achieve and maintain tolerance to peanuts, improving the management of peanut allergies in children.
Who should consider this trial
Good fit: Ideal candidates for this study are children with confirmed IgE-mediated peanut allergies who have reacted to less than 100 mg of peanut protein.
Not a fit: Patients without a confirmed peanut allergy or those with severe asthma or other significant health issues 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 peanut allergies by potentially allowing them to tolerate peanuts.
How similar studies have performed: Previous studies on oral immunotherapy for food allergies have shown promising results, indicating that this approach is both effective and safe.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Warsaw
- Department of Pediatric Pneumonology and Allergy, Medical University of Warsaw — Warsaw, Poland (Recruiting)
Study contacts
- Principal investigator: Klementyna Łyżwa, MD — Department of Pediatric Pneumonology and Allergy, Medical University of Warsaw
- Study coordinator: Klementyna Łyżwa, MD
- Email: klementyna.jozwik@gmail.com
- Phone: +488607153221
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.