Clinical trial NCT05740163: Oral Immunotherapy for Egg Allergy in Children Aged 6 to 16
Official title: Oral Immunotherapy for Egg Allergy in Children Aged 6 to 16
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Egg Allergy
Keywords: Oral immunotherapy
Egg allergy
Children
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
Collaborators: name: University of Oulu
name: Oulu University Hospital
First posted: 2023-02-22
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility 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)

Primary outcomes:
measure: Efficacy of oral egg immunotherapy
timeFrame: Within 12 months of study
Secondary outcomes:
measure: Safety of oral egg immunotherapy
timeFrame: Within 12 months of study
measure: Specification of adverse reactions during egg OIT in patients without asthma
timeFrame: Within 12 months of study
measure: Number and severity of anaphylactic reactions during OIT without asthma
timeFrame: Within 12 months of study
measure: Specification of adverse reactions during OIT in patients with asthma
timeFrame: Within 12 months of study
measure: Number and severity of anaphylactic reactions durin OIT in patients with asthma
timeFrame: Within 12 months of study
measure: Effect of immunotherapy on the level of whole serum IgE
timeFrame: Within 12 months of study
measure: Effect of immunotherapy on the level of specific egg IgE (sIgE)
timeFrame: Within 12 months of study
measure: Effect of immunotherapy on white blood cells
timeFrame: Within 12 months of study
measure: Effect of immunotherapy on the level of egg IgG4 (sIgG4)
timeFrame: Within 12 months of study
measure: Effect of immunotherpay on heat stable, egg components
timeFrame: Within 12 months of study
measure: Effect of immunotherpay on the activity of eosinophils
timeFrame: Within 12 months of study
measure: Changes in parameters describing lung inflammation in patients with asthma
timeFrame: Within 12 months of study
measure: Changes in parameters describing lung inflammation in patients without asthma
timeFrame: Within 12 months of study
measure: Changes in lung function parameters during OIT in patients with asthma and > 7 years of age
timeFrame: Within 12 months of study
measure: Changes in lung function parameters during OIT in patients with asthma < 7 years of age
timeFrame: Within 12 months of study
measure: Changes in lung function parameters during OIT in patients without asthma and > 7 years of age
timeFrame: Within 12 months of study
measure: Changes in lung function parameters during OIT in patients without asthma and < 7 years of age
timeFrame: Within 12 months of study
measure: Recording of asthma symptoms during egg OIT in patients with asthma
timeFrame: Within 12 months of study
measure: Recording of asthma symptoms during egg OIT in patients without asthma
timeFrame: Within 12 months of study
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Oulu University Hospital
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
affiliation: Tampere University Hospital
name: Rüdiger Schultz, MD., PhD
role: PRINCIPAL_INVESTIGATOR
References: