Egg Allergy Oral Desensitization

NCT ID: NCT04027465

Last Updated: 2022-07-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-03
• Study Completion Date: 2023-07-02

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

Conditions

Egg Protein Allergy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Treatment

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

Group Type: EXPERIMENTAL

Egg allergy oral desensitization

Intervention Type: DIETARY_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

Interventions

Egg allergy oral desensitization

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

Intervention Type: DIETARY_SUPPLEMENT

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 .

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER

Sponsor Role: lead

Responsible Party

Bruce Mazer

Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Montreal Children's Hospital

Montreal, Quebec, Canada

Duncan Lejtenyi

Montreal, Quebec, Canada

Countries

Canada

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2017-3182

Identifier Type: -

Identifier Source: org_study_id