Clinical Trials

Egg Allergy Oral Desensitization

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	6 Years - 20 Years
Gender	All

More Inclusion & 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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04027465
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	McGill University Health Centre/Research Institute of the McGill University Health Centre
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Active, not recruiting
Countries	Canada
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Egg Protein Allergy

Additional Details

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

Arms & Interventions

Arms

No Intervention: 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

Experimental: 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

Interventions

Dietary Supplement: - 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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Montreal Children's Hospital, Montreal, Quebec, Canada

Status

Address

Montreal Children's Hospital

Montreal, Quebec, H4A 3J1

Duncan Lejtenyi, Montreal, Quebec, Canada