Egg Allergy Oral Desensitization
- Conditions
- Egg Protein Allergy
- Interventions
- Dietary Supplement: Egg allergy oral desensitization
- Registration Number
- NCT04027465
- Lead Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
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Children 6 years and older
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Informed consent form signed by the parents or legal guardian (appendix B).
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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
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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.
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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 .
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment Egg allergy oral desensitization 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
- Primary Outcome Measures
Name Time Method Efficacy of desensitization in egg allergic patients as assessed by presence or absence of allergic symptoms during a blinded, placebo controlled oral food challenge 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
- Secondary Outcome Measures
Name Time Method Change from baseline over the immunotherapy process of egg specigic IgE levels 18 months Measurement of egg specigic IgE before, during and after the desensitization process
Change from baseline over the immunotherapy process of egg specigic IgA levels 18 months Measurement of egg specigic IgA before, during and after the desensitization process
Change from baseline over the immunotherapy process of Regulatory T cell levels 18 months Measurement of Regulatory T cell levels, before, during and after the desensitization process
Change from baseline over the immunotherapy process of egg specigic IgG4 levels 18 months Measurement of egg specigic IgG4 before, during and after the desensitization process
Change from baseline over the immunotherapy process of of DNA methylation levels 18 months Measurement of DNA methylation levels before, during and after the desensitization process
Change from baseline over the immunotherapy process of mast cell activation, as measured by CD63 levels 18 months Measurement of mast cell activation before, during and after the desensitization process as measured by CD63 expression
Trial Locations
- Locations (2)
Montreal Children's Hospital
🇨🇦Montreal, Quebec, Canada
Duncan Lejtenyi
🇨🇦Montreal, Quebec, Canada