Egg Protein AllergyNCT04027465
Egg Allergy Oral Desensitization
A study testing Egg allergy oral desensitization in people with Egg Protein Allergy, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 2 sites in Canada.
Trial 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 Read more about this study
- Who is it for?
- Ages 6 to 20 years
- Conditions the study is for
- Egg Protein Allergy
- What is being tested?
- Egg allergy oral desensitization
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesCanada
- Study dates
- 3 Jul 2018to 2 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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:
- 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).
Who cannot join
- 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 .
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Montreal Children's Hospital
Montreal, Quebec, H4A 3J1
Duncan Lejtenyi
Montreal, Quebec, H4A3J1
About this study
Official title: Egg Desensitization and Induction of Tolerance in Children
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
Read the 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
- To determine the rate of desensitization to egg.
- To characterize predictors of successful desensitization.
- To characterize molecular mechanisms involved in the process of desensitization
These objectives will be evaluated through a randomized controlled trial
- Conditions
- Egg Protein Allergy
- Being tested
- Egg allergy oral desensitization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Egg allergy oral desensitizationDietary supplement
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
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | 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 |
| Treatment | Experimental | 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 Receives: Dietary Supplement: Egg allergy oral desensitization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 18 months
Secondary outcomes (6)
Change from baseline over the immunotherapy process of egg specigic IgE levels
Measurement of egg specigic IgE before, during and after the desensitization process
Measured: 18 months
Change from baseline over the immunotherapy process of egg specigic IgA levels
Measurement of egg specigic IgA before, during and after the desensitization process
Measured: 18 months
Change from baseline over the immunotherapy process of egg specigic IgG4 levels
Measurement of egg specigic IgG4 before, during and after the desensitization process
Measured: 18 months
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
Measured: 18 months
Change from baseline over the immunotherapy process of of DNA methylation levels
Measurement of DNA methylation levels before, during and after the desensitization process
Measured: 18 months
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
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2019
- Study start3 Jul 2018
- Primary completion2 Jul 2023 (estimated)
- Study completion2 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Egg Protein AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomixed controlled trial
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruce Mazer, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04027465
- Sponsor's protocol ID
- 2017-3182
- Status last verified
- Jul 2022
- First submitted
- 24 May 2018
- Last updated
- 26 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Egg Desensitization and Induction of Tolerance in Children
- ClinicalTrials.gov ID
- NCT04027465
- Acronym / sponsor ID
- 2017-3182
- Conditions
- Egg Protein Allergy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- 3 Jul 2018 (actual)
- Primary completion
- 2 Jul 2023 (estimated)
- Study completion
- 2 Jul 2023 (estimated)
- First posted
- 22 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- To determine the rate of desensitization to egg.
- To characterize predictors of successful desensitization.
- To characterize molecular mechanisms involved in the process of desensitization
These objectives will be evaluated through a randomized controlled trial
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomixed controlled trial
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –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 |
| Treatment | Experimental | Dietary Supplement: Egg allergy oral desensitizationFollowing 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 |
Who may qualify
- Ages
- 6 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Egg allergy oral desensitizationSubjects 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 | Dietary supplement | Treatment |
Primary outcome
Efficacy of desensitization in egg allergic patients as assessed by presence or absence of allergic symptoms during a blinded, placebo controlled oral food challenge
Time frame: 18 months
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
6 secondary outcomes
Change from baseline over the immunotherapy process of egg specigic IgE levels
Time frame: 18 months
Change from baseline over the immunotherapy process of egg specigic IgA levels
Time frame: 18 months
Change from baseline over the immunotherapy process of egg specigic IgG4 levels
Time frame: 18 months
Change from baseline over the immunotherapy process of mast cell activation, as measured by CD63 levels
Time frame: 18 months
Change from baseline over the immunotherapy process of of DNA methylation levels
Time frame: 18 months
Change from baseline over the immunotherapy process of Regulatory T cell levels
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
- Individual participant dataSharing planned: No
Related trials for Egg Protein Allergy
Not yet recruiting
Efficacy and Safety of Egg Ladders in Children With IgE-Mediated Hen's Egg Protein Allergy
Food Allergy, Egg Allergy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Egg allergy oral desensitization in people with Egg Protein Allergy, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of desensitization in egg allergic patients as assessed by presence or absence of allergic symptoms during a blinded, placebo controlled oral food challenge (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2022.