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Oral Immunotherapy for Egg Allergy in Children Aged 6 to 16

Study Purpose

The aim of the 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. 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 6 Years - 16 Years
Gender All
More 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)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Tampere University Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Rüdiger Schultz, MD., PhD
Principal Investigator Affiliation Tampere University Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Recruiting
Countries Finland

The disease, disorder, syndrome, illness, or injury that is being studied.

Egg Allergy
Additional Details

The prevalence of egg allergy among children varies from 0.5% to 3% and is thus the second most common food allergy in children. Until recently, the only treatment for egg allergy was in many cases a life-long avoidance of egg protein. Due to the large number of egg-allergic children, oral immunotherapy (OIT) to egg has been suggested to be of probable benefit to cure children with egg-allergy. Several studies have been conducted to evaluate the safety and clinical outcome of egg OIT. However, concerning efficacy and safety of egg OIT more data, and alternative procedures are required to gain a safe, simple and inexpensive immunotherapy protocol . Previous egg OIT studies have mainly used egg white in the immunotherapy, rather than more natural and inexpensive whole egg products. 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.

Arms & Interventions


Experimental: Egg allergy with asthma with intervention

Immunotherapy Egg product including egg white and yolk allergens

Experimental: Egg allergy without asthma with intervention

Immunotherapy Egg product including egg white and yolk allergens

No Intervention: Egg allergy with asthma without intervention

No intervention, control

No Intervention: Egg allergy without asthma without intervention

No intervention, control


Dietary Supplement: - 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Oulu University Hospital, Oulu, Finland




Oulu University Hospital

Oulu, , 90230

Site Contact

Petri Kulmala, Clinical Professor



Tampere University Hospital, Tampere, Finland




Tampere University Hospital

Tampere, , 33520

Site Contact

Rüdiger Schultz, MD., PhD



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