Clinical trial NCT06256146: Investigating Modified Protocols of Oral Immunotherapy to Validate Efficacy and Safety
Official title: Investigating Modified Protocols of Oral Immunotherapy to Validate Efficacy and Safety
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Peanut Allergy
Milk Allergy, Cow's
Egg Allergy
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: The Hospital for Sick Children
First posted: 2024-02-13
Enrollment: 360
Sex: ALL
Minimum age (years): 2
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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).

Primary outcomes:
measure: Rate of anaphylaxis in different Oral Immunotherapy protocols
timeFrame: 3 years
Secondary outcomes:
measure: Efficacy of different Oral Immunotherapy protocols
timeFrame: 3 years
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Research Institute of the McGill University Health Centre
state: Quebec
Study officials:
affiliation: MUHC-RI
name: Moshe Ben-Shoshan, MD
role: PRINCIPAL_INVESTIGATOR
References: