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TRADE Trial - Tree Nut Immunotherapy Route Development and Evaluation

TRADE Trial - Tree Nut Immunotherapy Route Development and Evaluation

Recruiting
1-16 years
All
Phase N/A

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Overview

Tree nut immunotherapy Route Assessment and DEvelopment (TRADE) is a randomized controlled trial that evaluates the efficacy and safety of sublingual immunotherapy and lower, more tolerable, doses of oral immunotherapy than currently in use.

Eligibility

Inclusion Criteria:

  • Allergic to tree nut with baseline threshold of 444 mg protein or less and provides consent, and where applicable, assent.

Exclusion Criteria:

  1. History of anaphylaxis to tree nut severe enough to cause shock, syncope, or intubation
  2. Eosinophilic or other inflammatory gastrointestinal disease within the past 2 years
  3. Severe (GINA severity class 5) or uncontrolled asthma including exacerbation within past 6 months
  4. Use of biologics, other food immunotherapy or experimental treatment in past 6 months.
  5. Ongoing other allergic diseases severe enough to preclude discontinuing antihistamines for 7 days prior to assessment visits
  6. Pregnancy or significant medical condition (e.g., liver, kidney, gastrointestinal, cardiovascular, hematologic, or pulmonary disease; allergy to the oat-based placebo) which would put the participant at excessive risk for food allergic reactions as judged by local investigator

Study details
    Tree Nut Allergy
    Food Allergy

NCT05521711

Hamilton Health Sciences Corporation

8 June 2024

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