Clinical trial NCT04027465: Egg Allergy Oral Desensitization
Official title: Egg Desensitization and Induction of Tolerance in Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Egg Protein Allergy
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2019-07-22
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomixed controlled trial
Primary purpose: TREATMENT

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

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 .

Primary outcomes:
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
timeFrame: 18 months
Secondary outcomes:
measure: Change from baseline over the immunotherapy process of egg specigic IgE levels
timeFrame: 18 months
measure: Change from baseline over the immunotherapy process of egg specigic IgA levels
timeFrame: 18 months
measure: Change from baseline over the immunotherapy process of egg specigic IgG4 levels
timeFrame: 18 months
measure: Change from baseline over the immunotherapy process of mast cell activation, as measured by CD63 levels
timeFrame: 18 months
measure: Change from baseline over the immunotherapy process of of DNA methylation levels
timeFrame: 18 months
measure: Change from baseline over the immunotherapy process of Regulatory T cell levels
timeFrame: 18 months
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal Children's Hospital
state: Quebec
city: Montreal
country: Canada
facility: Duncan Lejtenyi
state: Quebec
Study officials:
References: