Oral immunotherapy for children with egg allergy
Oral Immunotherapy for Egg Allergy in Children Aged 6 to 16
This study is testing a new treatment using cooked whole eggs to see if it can help children with egg allergies eat eggs safely and reduce their allergic reactions.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 6 Years to 16 Years |
| Sex | All |
| Sponsor | Tampere University Hospital Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 2 sites (Oulu and 1 other locations) |
| Trial ID | NCT05740163 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of a 12-month oral immunotherapy (OIT) protocol using a cooked whole egg product, which includes both yolk and egg white, for children aged 6 to 16 with egg allergies. The researchers hypothesize that this method will reduce the risk of severe allergic reactions and may allow for a normalized diet. The study will also investigate the immune responses to the whole egg OIT and compare its efficacy and side effects in children with and without asthma. By using a whole egg product, the study seeks to provide a more natural and cost-effective approach to treating egg allergies.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 6 to 16 who have a confirmed egg allergy and are currently avoiding egg in their diet.
Not a fit: Patients who may not benefit from this study include those with uncontrolled asthma, significant cardiovascular disease, or other serious health conditions.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for children with egg allergies by allowing them to safely consume egg products.
How similar studies have performed: Previous studies on oral immunotherapy for egg allergies have shown promise, but this approach using whole egg products is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 6 to 16 years * Elevated spesific serum IgE to egg (\> 5 kU/l) and/or positive skin prick to egg allergen * Positive oral food challenge for egg or anaphylaxis reaction to egg within the 6 months * Diet free from egg in any form Exclusion Criteria: * Age less than 6 years or more than 16 years * Poor asthma control or uncontrolled asthma * Severe/significant cardiovascular disease * Autoimmune disease * Malignancy * Medication: beta bloker, angiotensin-converting-enzyme inhibitors (ACE inhibitors), Monoamine oxidase inhibitors (MAOIs) * Poor compliance * Fear of immunotherapy * Desensitization to alfa-gal-protein (mammalian meat allergy)
Where this trial is running
Oulu and 1 other locations
- Oulu University Hospital — Oulu, Finland (Recruiting)
- Tampere University Hospital — Tampere, Finland (Recruiting)
Study contacts
- Principal investigator: Rüdiger Schultz, MD., PhD — Tampere University Hospital
- Study coordinator: Rüdiger Schultz, MD., PhD
- Email: rudiger.schultz58@gmail.com
- Phone: +358
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.