Investigating Modified Protocols of Oral Immunotherapy to Validate Efficacy and Safety

Study Purpose

Protocols for Oral Immunotherapy (OIT) for the main food allergens have been recently incorporated in clinical practice for food allergies and their clinical benefits have been acknowledged in European and Canadian official guidelines. There has been some reluctance in both clinicians and patients to implement these therapies, primarily because of the risk of allergic reactions during the desensitization process. This study will investigate if protocols using low doses of a food allergen or processed versions of the allergen can be both effective in conferring desensitization while inducing fewer allergic symptoms during the desensitization process.

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	2 Years - 40 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- A history suggestive of immediate allergy to the food.

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.

- The presence of at least one of the following confirmatory tests: - Positive SPT to the culprit food allergen (weal diameter 3 mm larger than that of the normal saline control).

The allergens used will be commercial extracts of the foods (Omega Labs, Toronto, Ontario).

- Detection of serum specific IgE (>0.35 kU/L) to the culprit food or any of its proteins, measured by fluorescence enzyme immunoassay (Phadia, CAP System, Uppsala, Sweden).

Exclusion Criteria:

- Patients who have uncontrolled respiratory disease (asthma, cystic fibrosis, etc.) - Patients who present with intercurrent disease active at the time of starting desensitization.

- Non IgE mediated or non-immunological adverse reactions to milk or peanuts.

- Malignant or immunopathological diseases and/or severe primary or secondary immune deficiencies.

- Patients receiving oral immunosuppressor therapy.

- Patients receiving β-blockers (including topical formulations), or who receive daily doses of NSAIDs, aspirin or ACE inhibitors for cardiac issues.

- Associated diseases contraindicating the use of epinephrine: cardiovascular disease, severe hypertension or hypotension.

- Patients diagnosed with eosinophilic gastrointestinal disorders, including patients with a history of antacid use for reflux related to food impaction or with a history of esophageal spasm.

- Patients already tolerating processed/cooked forms of the food (e.g.,baked goods with milk).

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.	NCT06256146
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.	Moshe Ben-Shoshan, MD
Principal Investigator Affiliation	MUHC-RI
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Canada
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Peanut Allergy, Milk Allergy, Cow's, Egg Allergy

Arms & Interventions

Arms

Experimental: Standard Protocol - High Dose Arm

Subjects will progress through desensitization to a high maintenance dose - 1200 mg of crushed peanut, 200 ml of milk or 1200 mg of egg powder.

Experimental: Modified Protocol - Low Dose Arm

Subjects will progress through desensitization to a low maintenance dose - 120 mg of crushed peanut, 50 ml of milk or 300 mg of egg powder.

Experimental: Modified Protocol - Cooked/Transformed Allergen Arm

Subjects will begin desensitization with cooked versions of the allergen (muffins in the case of egg and milk) or transformed versions (Bamba puffs for peanut). They will progress up to a full muffin or 4 Bamba puffs (for egg/milk and peanut respectively). Once subjects have reached these doses, they will transition to doses of pure allergen. They will then progress to the same top dose as subjects in the High Dose Arm.

Interventions

Other: - Food allergy desensitization / Oral Immunotherapy

Participants consume increasing doses of allergenic food daily until they reach a maintenance dose. In the case of the High Dose Arm, participants will progress to a daily dose of either 1200 mg, 300 mg or 200 ml of egg, peanut or milk respectively. Participants randomized to the Low Dose Arm also begin by consuming small amounts of the allergenic food, gradually increasing the daily dose. However, participants in this group only progress to 300 ml, 30 mg or 50 ml daily dose of egg, peanut or milk respectively. The Cooked/Transformed Allergen Arm begins the desensitization with a cooked or transformed form of the allergen - muffins in the case of egg or milk, Bamba puffs in the case of peanut. Participants take increasing amounts of these products (one muffin for egg and milk and four Bamba puffs for peanut) then transition to egg, milk or peanut. Participants then continue their dose progression, getting to 1200 mg, 200 ml or 300 mg for egg, milk and peanut respectively.

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, Quebec, Canada

Status

Recruiting

Address

Research Institute of the McGill University Health Centre

Montreal, Quebec, H4A 3J1

Site Contact

Duncan Lejtenyi, MSc

[email protected]

514-934-1934 #22369

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