Egg Allergy Oral Desensitization

McGill University

Status: Active, not recruiting

Conditions: Egg Protein Allergy

Treatments: Dietary Supplement: Egg allergy oral desensitization

Study type: Interventional

Funder types: Other

Identifiers

NCT04027465

2017-3182

Details and patient eligibility

About

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

Full 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

Enrollment: 50 estimated patients

Sex: All

Ages: 6 to 20 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 .

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Control

No Intervention group

Description:

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 group

Description:

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

Treatment:

Dietary Supplement: Egg allergy oral desensitization