Status:
UNKNOWN
Egg Allergy Oral Desensitization
Lead Sponsor:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Conditions:
Egg Protein Allergy
Eligibility:
All Genders
6-20 years
Phase:
NA
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 contro...
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 ...
Eligibility Criteria
Inclusion
- 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 .
Exclusion
Key Trial Info
Start Date :
July 3 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 2 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04027465
Start Date
July 3 2018
End Date
July 2 2023
Last Update
July 26 2022
Active Locations (2)
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1
Montreal Children's Hospital
Montreal, Quebec, Canada, H4A 3J1
2
Duncan Lejtenyi
Montreal, Quebec, Canada, H4A3J1