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Oral Immunotherapy for Egg Allergy in Children Aged 6 to 16

Primary Purpose

Egg Allergy

Status
Recruiting
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Egg product including egg white and yolk allergens
Sponsored by
Tampere University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Egg Allergy focused on measuring Oral immunotherapy, Egg allergy, Children

Eligibility Criteria

6 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Oulu University HospitalRecruiting
  • Tampere University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

No Intervention

No Intervention

Arm Label

Egg allergy with asthma with intervention

Egg allergy without asthma with intervention

Egg allergy with asthma without intervention

Egg allergy without asthma without intervention

Arm Description

Immunotherapy Egg product including egg white and yolk allergens

Immunotherapy Egg product including egg white and yolk allergens

No intervention, control

No intervention, control

Outcomes

Primary Outcome Measures

Efficacy of oral egg immunotherapy
Total number of patients who achieved tolerance to egg protein during OIT (negative egg challenge) compared to the number of patients who received only partly tolerance or failed to develop any level of unresponsiveness.

Secondary Outcome Measures

Safety of oral egg immunotherapy
Total number of participants with adverse events, and total number of adverse events evaluating the safety of our method
Specification of adverse reactions during egg OIT in patients without asthma
Subjective evaluation and grading of symptoms from different organ sides during OIT, using visual analogue score 0-10 (VAS) in patients without asthma
Number and severity of anaphylactic reactions during OIT without asthma
Number and severity of anaphylaxis during OIT (Grading of anaphylaxis using Samsons criteria, grade1-5) in patients without asthma
Specification of adverse reactions during OIT in patients with asthma
Subjective evaluation and grading of symptoms from different organ sides during OIT, using visual analogue score 0-10 (VAS) in patients with asthma
Number and severity of anaphylactic reactions durin OIT in patients with asthma
Number and severity of anaphylaxis in patients with asthma (Grading of anaphylaxis using Samsons criteria, grade 1-5) in patients with asthma.
Effect of immunotherapy on the level of whole serum IgE
Changing values in blood samples during OIT describing changes in whole IgE by determining values before OIT and after 6 and 12 months of OIT.
Effect of immunotherapy on the level of specific egg IgE (sIgE)
Changing values in blood samples during OIT describing changes in egg sIGE by determining values before OIT and after 6 and 12 months of OIT.
Effect of immunotherapy on white blood cells
Changing values in blood samples during OIT describing changes in the white blood-cell count by determining values before OIT and after 6 and 12 months of OIT.
Effect of immunotherapy on the level of egg IgG4 (sIgG4)
Changing values in blood samples during OIT describing changes in the egg sIgG4 by determining values before OIT and after 6 and 12 months of OIT.
Effect of immunotherpay on heat stable, egg components
Changing values in blood samples during OIT describing changes in the heat stable molecules of Gal d1 and Gal d2 by determining values before OIT and after 6 and 12 months of OIT.
Effect of immunotherpay on the activity of eosinophils
Changing values in blood samples during OIT describing changes in the level of eosinophilic cationic protein (ECP) by determining values before OIT and after 6 and 12 months of OIT.
Changes in parameters describing lung inflammation in patients with asthma
Comparison of values of exhaled nitric oxide (ppb) and serum ECP (ug/l) by comparing the results 6 and 12 months after starting OIT to baseline values before OIT.
Changes in parameters describing lung inflammation in patients without asthma
Comparison of values of exhaled nitric oxide (ppb) and serum ECP (ug/l) by comparing the results 6 and 12 months after starting OIT to baseline values before OIT.
Changes in lung function parameters during OIT in patients with asthma and > 7 years of age
Effect of OIT on parameters describing lung function in children over > 7 years of age employing flow-volume spirometry. Changing levels of FEV1 (l) and PEF (l/s) will be recorded.
Changes in lung function parameters during OIT in patients with asthma < 7 years of age
Effect of OIT on parameters describing lung function in children < 7 years of age employing impedance oscillometry. Changing levels of 5Hz resistance (R5, kPa/l/s) and total impedance (Z5, kPa/l/s) will be recorded.
Changes in lung function parameters during OIT in patients without asthma and > 7 years of age
Effect of OIT on parameters describing lung function in children over > 7 years of age and without ashma employing flow-volume spirometry. Changing levels of FEV1 (l) and PEF (l/s) will be recorded.
Changes in lung function parameters during OIT in patients without asthma and < 7 years of age
Effect of OIT on parameters describing lung function in children < 7 years of age and without asthma employing impedance oscillometry. Changing levels of 5Hz resistance (R5, kPa/l/s) and total impedance (Z5, kPa/l/s) will be recorded.
Recording of asthma symptoms during egg OIT in patients with asthma
Subjective evaluation and grading of asthmatic symptoms during OIT, using visual analogue score (VAS).
Recording of asthma symptoms during egg OIT in patients without asthma
Subjective evaluation and grading of asthmatic symptoms during OIT, using visual analogue score (VAS).

Full Information

First Posted
January 16, 2023
Last Updated
March 6, 2023
Sponsor
Tampere University Hospital
Collaborators
University of Oulu, Oulu University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05740163
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 30, 2019 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tampere University Hospital
Collaborators
University of Oulu, Oulu University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Egg Allergy
Keywords
Oral immunotherapy, Egg allergy, Children

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Egg allergy with asthma with intervention
Arm Type
Experimental
Arm Description
Immunotherapy Egg product including egg white and yolk allergens
Arm Title
Egg allergy without asthma with intervention
Arm Type
Experimental
Arm Description
Immunotherapy Egg product including egg white and yolk allergens
Arm Title
Egg allergy with asthma without intervention
Arm Type
No Intervention
Arm Description
No intervention, control
Arm Title
Egg allergy without asthma without intervention
Arm Type
No Intervention
Arm Description
No intervention, control
Intervention Type
Dietary Supplement
Intervention Name(s)
Egg product including egg white and yolk allergens
Intervention Description
Egg product either meatball or bread roll or bun including egg white and yolk allergens delivered orally in increasing dosages daily.
Primary Outcome Measure Information:
Title
Efficacy of oral egg immunotherapy
Description
Total number of patients who achieved tolerance to egg protein during OIT (negative egg challenge) compared to the number of patients who received only partly tolerance or failed to develop any level of unresponsiveness.
Time Frame
Within 12 months of study
Secondary Outcome Measure Information:
Title
Safety of oral egg immunotherapy
Description
Total number of participants with adverse events, and total number of adverse events evaluating the safety of our method
Time Frame
Within 12 months of study
Title
Specification of adverse reactions during egg OIT in patients without asthma
Description
Subjective evaluation and grading of symptoms from different organ sides during OIT, using visual analogue score 0-10 (VAS) in patients without asthma
Time Frame
Within 12 months of study
Title
Number and severity of anaphylactic reactions during OIT without asthma
Description
Number and severity of anaphylaxis during OIT (Grading of anaphylaxis using Samsons criteria, grade1-5) in patients without asthma
Time Frame
Within 12 months of study
Title
Specification of adverse reactions during OIT in patients with asthma
Description
Subjective evaluation and grading of symptoms from different organ sides during OIT, using visual analogue score 0-10 (VAS) in patients with asthma
Time Frame
Within 12 months of study
Title
Number and severity of anaphylactic reactions durin OIT in patients with asthma
Description
Number and severity of anaphylaxis in patients with asthma (Grading of anaphylaxis using Samsons criteria, grade 1-5) in patients with asthma.
Time Frame
Within 12 months of study
Title
Effect of immunotherapy on the level of whole serum IgE
Description
Changing values in blood samples during OIT describing changes in whole IgE by determining values before OIT and after 6 and 12 months of OIT.
Time Frame
Within 12 months of study
Title
Effect of immunotherapy on the level of specific egg IgE (sIgE)
Description
Changing values in blood samples during OIT describing changes in egg sIGE by determining values before OIT and after 6 and 12 months of OIT.
Time Frame
Within 12 months of study
Title
Effect of immunotherapy on white blood cells
Description
Changing values in blood samples during OIT describing changes in the white blood-cell count by determining values before OIT and after 6 and 12 months of OIT.
Time Frame
Within 12 months of study
Title
Effect of immunotherapy on the level of egg IgG4 (sIgG4)
Description
Changing values in blood samples during OIT describing changes in the egg sIgG4 by determining values before OIT and after 6 and 12 months of OIT.
Time Frame
Within 12 months of study
Title
Effect of immunotherpay on heat stable, egg components
Description
Changing values in blood samples during OIT describing changes in the heat stable molecules of Gal d1 and Gal d2 by determining values before OIT and after 6 and 12 months of OIT.
Time Frame
Within 12 months of study
Title
Effect of immunotherpay on the activity of eosinophils
Description
Changing values in blood samples during OIT describing changes in the level of eosinophilic cationic protein (ECP) by determining values before OIT and after 6 and 12 months of OIT.
Time Frame
Within 12 months of study
Title
Changes in parameters describing lung inflammation in patients with asthma
Description
Comparison of values of exhaled nitric oxide (ppb) and serum ECP (ug/l) by comparing the results 6 and 12 months after starting OIT to baseline values before OIT.
Time Frame
Within 12 months of study
Title
Changes in parameters describing lung inflammation in patients without asthma
Description
Comparison of values of exhaled nitric oxide (ppb) and serum ECP (ug/l) by comparing the results 6 and 12 months after starting OIT to baseline values before OIT.
Time Frame
Within 12 months of study
Title
Changes in lung function parameters during OIT in patients with asthma and > 7 years of age
Description
Effect of OIT on parameters describing lung function in children over > 7 years of age employing flow-volume spirometry. Changing levels of FEV1 (l) and PEF (l/s) will be recorded.
Time Frame
Within 12 months of study
Title
Changes in lung function parameters during OIT in patients with asthma < 7 years of age
Description
Effect of OIT on parameters describing lung function in children < 7 years of age employing impedance oscillometry. Changing levels of 5Hz resistance (R5, kPa/l/s) and total impedance (Z5, kPa/l/s) will be recorded.
Time Frame
Within 12 months of study
Title
Changes in lung function parameters during OIT in patients without asthma and > 7 years of age
Description
Effect of OIT on parameters describing lung function in children over > 7 years of age and without ashma employing flow-volume spirometry. Changing levels of FEV1 (l) and PEF (l/s) will be recorded.
Time Frame
Within 12 months of study
Title
Changes in lung function parameters during OIT in patients without asthma and < 7 years of age
Description
Effect of OIT on parameters describing lung function in children < 7 years of age and without asthma employing impedance oscillometry. Changing levels of 5Hz resistance (R5, kPa/l/s) and total impedance (Z5, kPa/l/s) will be recorded.
Time Frame
Within 12 months of study
Title
Recording of asthma symptoms during egg OIT in patients with asthma
Description
Subjective evaluation and grading of asthmatic symptoms during OIT, using visual analogue score (VAS).
Time Frame
Within 12 months of study
Title
Recording of asthma symptoms during egg OIT in patients without asthma
Description
Subjective evaluation and grading of asthmatic symptoms during OIT, using visual analogue score (VAS).
Time Frame
Within 12 months of study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rüdiger Schultz, MD., PhD
Phone
+358
Email
rudiger.schultz58@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rüdiger Schultz, MD., PhD
Organizational Affiliation
Tampere University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oulu University Hospital
City
Oulu
ZIP/Postal Code
90230
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Petri Kulmala, Clinical Professor
Phone
+35883155534
Email
petri.kulmala@oulu.fi
First Name & Middle Initial & Last Name & Degree
Lotta Kinnunen, MD., PhD
Phone
+35883155825
First Name & Middle Initial & Last Name & Degree
Lotta Kinnunen, MD., PhD
First Name & Middle Initial & Last Name & Degree
Teija Dunder, MD., PhD
First Name & Middle Initial & Last Name & Degree
Petri Kulmala, MD., PhD
Facility Name
Tampere University Hospital
City
Tampere
ZIP/Postal Code
33520
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rüdiger Schultz, MD., PhD
Email
rudiger.schultz@pirha.fi
First Name & Middle Initial & Last Name & Degree
Lauri Lehtimäki, MD., PhD
First Name & Middle Initial & Last Name & Degree
Heli Aldénv, M.Sc.
First Name & Middle Initial & Last Name & Degree
Iida Ojaniemi, MD
First Name & Middle Initial & Last Name & Degree
Jussi Karjalainen, MD., PhD
First Name & Middle Initial & Last Name & Degree
Heini Huhtala, M.Sc.
First Name & Middle Initial & Last Name & Degree
Susanna Salmivesi, MD., PhD
First Name & Middle Initial & Last Name & Degree
Juho Kivistö, MD., PhD
First Name & Middle Initial & Last Name & Degree
Rüdiger Schultz, MD., PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Oral Immunotherapy for Egg Allergy in Children Aged 6 to 16

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