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Egg Allergy Oral Desensitization

Primary Purpose

Egg Protein Allergy

Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Egg allergy oral desensitization
Sponsored by
McGill University Health Centre/Research Institute of the McGill University Health Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Egg Protein Allergy

Eligibility Criteria

6 Years - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Children 6 years and older
  • Informed consent form signed by the parents or legal guardian (appendix B).
  • A history suggestive of immediate allergy to egg. A convincing clinical history of an IgE mediated reaction to a specific food will be defined as a minimum of 2 mild signs/symptoms or 1 moderate or 1 severe sign/symptom that was likely IgE mediated and occurred within 120 minutes after ingestion or contact (or inhalation in the case of fish and shellfish). Reactions will be considered mild if they involve pruritus, urticaria, flushing, or rhinoconjunctivitis; moderate if they involve angioedema, throat tightness, gastrointestinal complaints, or breathing difficulties (other than wheeze); and severe if they involve wheeze, cyanosis, or circulatory collapse
  • Positive oral challenge test to egg. Oral challenges will be performed with Meringue Powder according to the recommendations of the position paper of the European Academy of Allergology and Clinical Immunology (68)and in an open manner (appendix C). When subjective symptoms will appear (oral pruritus, abdominal discomfort), the challenge tests will be blinded.

  • The presence of at least one of the following confirmatory tests:

    i) Positive SPT to egg or its proteins (weal diameter 3 mm larger than that of the normal saline control). The allergens used will be commercial extracts of egg (Omega Labs, Toronto, Ontario). OR ii) Detection of serum specific IgE (>0.35 kU/L) to egg or any of its proteins (ovalbumin, ovomucoid, lysozyme and conalbumin), measured by fluorescence enzyme immunoassay (Phadia, CAP System, Uppsala, Sweden).

Exclusion criteria.

  • Patients who are unstable from a respiratory point of view ..
  • Patients who present with intercurrent disease at the time of starting desensitization.
  • Non-IgE-mediated or non-immunological adverse reactions to nuts.
  • Malignant or immunopathological diseases and/or severe primary or secondary immune deficiencies.
  • Patients receiving immunosuppressor therapy
  • Patients receiving β-blockers (including topical formulations).
  • Associated diseases contraindicating the use of epinephrine: cardiovascular disease or severe hypertension.
  • Patients diagnosed with eosinophilic gastrointestinal disorder .

Sites / Locations

  • Montreal Children's Hospital
  • Duncan Lejtenyi

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Treatment

Arm Description

Following randomization, this arm will receive no intervention. After twelve months, participants in this group will undergo a singe-blind, placebo-controlled oral food challenge

Following randomization, participants in this group will receive escalating doses of egg protein, up to a dose of 300 mg. Once they attain that dose, they will maintain it for six months. At the end of this maintenance period, they will undergo a singe-blind, placebo-controlled oral food challenge

Outcomes

Primary Outcome Measures

Efficacy of desensitization in egg allergic patients as assessed by presence or absence of allergic symptoms during a blinded, placebo controlled oral food challenge
Comparison of participants randomized to treatments arms who egg desensitization compared to participants randomized to the control group. This is measured by whether a participant is able to tolerate a total dose of 6043 mg powdered egg during an oral food challenge

Secondary Outcome Measures

Change from baseline over the immunotherapy process of egg specigic IgE levels
Measurement of egg specigic IgE before, during and after the desensitization process
Change from baseline over the immunotherapy process of egg specigic IgA levels
Measurement of egg specigic IgA before, during and after the desensitization process
Change from baseline over the immunotherapy process of egg specigic IgG4 levels
Measurement of egg specigic IgG4 before, during and after the desensitization process
Change from baseline over the immunotherapy process of mast cell activation, as measured by CD63 levels
Measurement of mast cell activation before, during and after the desensitization process as measured by CD63 expression
Change from baseline over the immunotherapy process of of DNA methylation levels
Measurement of DNA methylation levels before, during and after the desensitization process
Change from baseline over the immunotherapy process of Regulatory T cell levels
Measurement of Regulatory T cell levels, before, during and after the desensitization process

Full Information

First Posted
May 24, 2018
Last Updated
July 25, 2022
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
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1. Study Identification

Unique Protocol Identification Number
NCT04027465
Brief Title
Egg Allergy Oral Desensitization
Official Title
Egg Desensitization and Induction of Tolerance in Children
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 3, 2018 (Actual)
Primary Completion Date
July 2, 2023 (Anticipated)
Study Completion Date
July 2, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre

4. Oversight

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

5. Study Description

Brief Summary
This study evaluates whether tolerance to eggs can be induced in patients through a process of oral immunotherapy. Participants will be randomized into groups receiving oral immunotherapy and a control group that will receive no intervention
Detailed Description
The investigators are proposing to initiate a study assessing a common desensitization protocol for egg allergy. This study would enable the investigators to better determine the potential benefit of desensitization in individuals with egg allergy. More specifically, the investigators will address the following research objectives: Objectives A. To develop a protocols for egg desensitization B. To determine the rate of desensitization to egg. C. To characterize predictors of successful desensitization. D. To characterize molecular mechanisms involved in the process of desensitization These objectives will be evaluated through a randomized controlled trial

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Egg Protein Allergy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomixed controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Following randomization, this arm will receive no intervention. After twelve months, participants in this group will undergo a singe-blind, placebo-controlled oral food challenge
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Following randomization, participants in this group will receive escalating doses of egg protein, up to a dose of 300 mg. Once they attain that dose, they will maintain it for six months. At the end of this maintenance period, they will undergo a singe-blind, placebo-controlled oral food challenge
Intervention Type
Dietary Supplement
Intervention Name(s)
Egg allergy oral desensitization
Intervention Description
Subjects in the treatment will begin treatment by undergoing an egg oral challenge. This will confirm that the subject is still allergic to egg and establish the dose of egg the subject can tolerate. The last dose of egg tolerated during the challenge will serve as the first desensitization dose Subjects will then come to the research center every two weeks to receive their dose increases until they reach the maintenance dose of 300 mg. Subjects will then enter the maintenance phase for one year. During this period they will undergo another oral food challenge one month after attaining the maintenance dose
Primary Outcome Measure Information:
Title
Efficacy of desensitization in egg allergic patients as assessed by presence or absence of allergic symptoms during a blinded, placebo controlled oral food challenge
Description
Comparison of participants randomized to treatments arms who egg desensitization compared to participants randomized to the control group. This is measured by whether a participant is able to tolerate a total dose of 6043 mg powdered egg during an oral food challenge
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Change from baseline over the immunotherapy process of egg specigic IgE levels
Description
Measurement of egg specigic IgE before, during and after the desensitization process
Time Frame
18 months
Title
Change from baseline over the immunotherapy process of egg specigic IgA levels
Description
Measurement of egg specigic IgA before, during and after the desensitization process
Time Frame
18 months
Title
Change from baseline over the immunotherapy process of egg specigic IgG4 levels
Description
Measurement of egg specigic IgG4 before, during and after the desensitization process
Time Frame
18 months
Title
Change from baseline over the immunotherapy process of mast cell activation, as measured by CD63 levels
Description
Measurement of mast cell activation before, during and after the desensitization process as measured by CD63 expression
Time Frame
18 months
Title
Change from baseline over the immunotherapy process of of DNA methylation levels
Description
Measurement of DNA methylation levels before, during and after the desensitization process
Time Frame
18 months
Title
Change from baseline over the immunotherapy process of Regulatory T cell levels
Description
Measurement of Regulatory T cell levels, before, during and after the desensitization process
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children 6 years and older Informed consent form signed by the parents or legal guardian (appendix B). A history suggestive of immediate allergy to egg. A convincing clinical history of an IgE mediated reaction to a specific food will be defined as a minimum of 2 mild signs/symptoms or 1 moderate or 1 severe sign/symptom that was likely IgE mediated and occurred within 120 minutes after ingestion or contact (or inhalation in the case of fish and shellfish). Reactions will be considered mild if they involve pruritus, urticaria, flushing, or rhinoconjunctivitis; moderate if they involve angioedema, throat tightness, gastrointestinal complaints, or breathing difficulties (other than wheeze); and severe if they involve wheeze, cyanosis, or circulatory collapse Positive oral challenge test to egg. Oral challenges will be performed with Meringue Powder according to the recommendations of the position paper of the European Academy of Allergology and Clinical Immunology (68)and in an open manner (appendix C). When subjective symptoms will appear (oral pruritus, abdominal discomfort), the challenge tests will be blinded. The presence of at least one of the following confirmatory tests: i) Positive SPT to egg or its proteins (weal diameter 3 mm larger than that of the normal saline control). The allergens used will be commercial extracts of egg (Omega Labs, Toronto, Ontario). OR ii) Detection of serum specific IgE (>0.35 kU/L) to egg or any of its proteins (ovalbumin, ovomucoid, lysozyme and conalbumin), measured by fluorescence enzyme immunoassay (Phadia, CAP System, Uppsala, Sweden). Exclusion criteria. Patients who are unstable from a respiratory point of view .. Patients who present with intercurrent disease at the time of starting desensitization. Non-IgE-mediated or non-immunological adverse reactions to nuts. Malignant or immunopathological diseases and/or severe primary or secondary immune deficiencies. Patients receiving immunosuppressor therapy Patients receiving β-blockers (including topical formulations). Associated diseases contraindicating the use of epinephrine: cardiovascular disease or severe hypertension. Patients diagnosed with eosinophilic gastrointestinal disorder .
Facility Information:
Facility Name
Montreal Children's Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Duncan Lejtenyi
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A3J1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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