Investigating new methods for oral immunotherapy in food allergies

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study explores modified protocols for oral immunotherapy (OIT) aimed at treating common food allergies, including peanut, milk, cow's, and egg allergies. It seeks to determine if using low doses or processed versions of allergens can effectively desensitize patients while minimizing allergic reactions during treatment. The study will involve patients with a history of immediate allergic reactions to specific foods and will utilize established diagnostic tests to confirm eligibility. By addressing concerns about safety and efficacy, this research aims to enhance the acceptance of OIT in clinical practice.

Why it matters

Who can join: the full rules

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).

Where it's running

• Research Institute of the McGill University Health Centre
  Montreal, Quebec, Canada Recruiting

Study contacts

• Principal investigator: Moshe Ben-Shoshan, MD — Muhc-Ri
• Study coordinator: Duncan Lejtenyi, M.Sc
• Email: duncan.lejtenyi@muhc.mcgill.ca
• Phone: 1-514-934-1934

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Remibrutinib for IgE-mediated peanut, milk, and egg allergy

  This study tests whether remibrutinib can help people with peanut, milk, or egg allergies by comparing it to placebo over 52 weeks.

  Recruiting at 22 sites Phase 3 Novartis · Birmingham, Alabama and 21 other locations · NCT07768371

• Long-term follow-up after 18 months of oral immunotherapy for peanut, egg, or milk allergy (5–15 years later)

  This follow-up will see if children and young people who completed an 18-month oral immunotherapy for peanut, egg, or milk allergy still have changes in allergy tests and better quality of life 5–15 years later.

  Recruiting Murdoch Childrens Research Institute · Parkville, Victoria · NCT07359183

• UKK-0018 immunotherapy for peanut allergy

  This trial will test whether injections of UKK-0018 can retrain the immune system to reduce allergic reactions in adults with peanut allergy.

  Recruiting at 5 sites Phase 1/2 Ukko Inc · Camperdown, New South Wales and 5 other locations · NCT07349212

• ENP-501 for people with and without peanut allergy

  This trial will test whether ENP-501 is safe and how it affects people aged 14–50 who either have a confirmed peanut allergy or regularly eat peanuts without problems.

  Recruiting Phase 1/2 N-Fold, LLC · Aurora, Colorado · NCT07117669

• Tezepelumab with Peanut OIT for Peanut Allergy

  This study tests whether adding tezepelumab to peanut oral immunotherapy can help people with peanut allergy build lasting tolerance.

  Recruiting at 6 sites Phase 2 National Institute of Allergy and Infectious Diseases (NIAID) · Little Rock, Arkansas and 9 other locations · NCT07015996

• Rush versus conventional oral immunotherapy for cow's milk and hen's egg allergy in children

  This test compares a faster 'rush' oral immunotherapy schedule with a conventional slower schedule to see which better helps children aged 6–16 with milk or egg allergy tolerate those foods.

  Recruiting Phase 2/3 Fundación de Investigación Biomédica - Hospital Universitario de La Princesa · Madrid · NCT06976775

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.