Oral Immunotherapy for Egg Allergy in Children Aged 6 to 16
NCT ID: NCT05740163
Last Updated: 2024-04-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
60 participants
INTERVENTIONAL
2019-12-30
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Study hypothesis: With this method the risk for severe allergic reaction to egg protein is reduced and the diet can partly or completely be normalized.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Immune Responses in Hen's Egg Oral Immunotherapy
NCT03744325
Treatment of Egg Allergy in Children Through Oral Desensitization (EGG OIT)
NCT00597558
Baked Egg or Egg Oral Immunotherapy for Children With Egg Allergy
NCT01846208
Oral Immunotherapy for Childhood Egg Allergy
NCT00461097
The Effect of Per Oral Immunotherapy in Severe IgE Mediated Egg, Milk, and Nut Allergy in Adults
NCT01822353
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The aim of this study is to determine the efficacy of a 12-month egg oral immunotherapy (OIT) protocol with a cooked whole egg product including yolk and egg white. Furthermore, the effects of whole egg OIT on humoral immune responses are investigated.
The investigators hypothesize that oral administration of a whole egg product with incremental dosing will increase the individual threshold for allergic reactivity to egg protein and may result in full tolerance without any reaction to egg.
Other study aims include investigating the differences in efficacy and side effects of whole-egg OIT in children with asthma and without asthma. In this study it is hypothesized that children with asthma have more symptoms than non-asthmatic children during the treatment. Furthemore, the level of asthma control during OIT is investigated.
The study is a prospective multicenter randomized open trial, investigating the efficacy, safety and immunological mechanisms of oral egg immunotherapy in children (aged 6 to 16). Children with egg allergy, egg avoidance diet, immediate reaction in a food challenge test for egg within the last six months and elevated serum egg-specific immunoglobulin E (IgE) levels, are recruited into the study. Children with uncontrolled asthma, severe cardiovascular disease and autoimmune disease or families with poor compliance are excluded from the study.
Study participants are divided into two groups: patients with asthma and without asthma. Both groups are separately randomized into immunotherapy or follow-up without the treatment. The immunotherapy and follow-up last 12 months in total. After 12 months of enrolment, participants in the follow-up group are entitled to take actively part in the egg OIT protocol.
In immunotherapy groups (asthma or no-asthma), meatball, bun or bread roll, including well-cooked whole-egg is given daily to the patients, starting from a minimal dosage (1/200 of the protein content of whole egg) and increasing the dosing every 1-2 weeks until a dosage of 1/5 of the protein content of a whole egg is reached. The initial dosage is given at the hospital outpatient clinic. The patients and their parents will be prepared for emergency treatment of severe allergic reactions and are given instructions to carry adequate medication with them. Patients in the intervention groups take levocetrizine 5 mg or cetirizine 10 mg daily until three months of maintenance dosage.
Blood samples, skin prick tests, lung function tests and exhaled nitric oxide levels are taken from all study participants. All the above-mentioned tests are taken before the therapy and at the time points of 6 and 12 months.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Egg allergy with asthma with intervention
Immunotherapy Egg product including egg white and yolk allergens
Egg product including egg white and yolk allergens
Egg product either meatball or bread roll or bun including egg white and yolk allergens delivered orally in increasing dosages daily.
Egg allergy without asthma with intervention
Immunotherapy Egg product including egg white and yolk allergens
Egg product including egg white and yolk allergens
Egg product either meatball or bread roll or bun including egg white and yolk allergens delivered orally in increasing dosages daily.
Egg allergy with asthma without intervention
No intervention, control
No interventions assigned to this group
Egg allergy without asthma without intervention
No intervention, control
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Egg product including egg white and yolk allergens
Egg product either meatball or bread roll or bun including egg white and yolk allergens delivered orally in increasing dosages daily.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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)
6 Years
16 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Oulu
OTHER
Oulu University Hospital
OTHER
Tampere University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Rudiger Schultz
Specialist in Pediatric Allergology
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Rüdiger Schultz, MD., PhD
Role: PRINCIPAL_INVESTIGATOR
Tampere University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Oulu University Hospital
Oulu, , Finland
Tampere University Hospital
Tampere, , Finland
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Lotta Kinnunen, MD., PhD
Role: backup
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Oral immunotherapy fo egg
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.