Actively Recruiting

Phase Not Applicable
Age: 1Year - 16Years
All Genders
Healthy Volunteers
NCT05521711

TRADE Trial - Tree Nut Immunotherapy Route Development and Evaluation

Led by Hamilton Health Sciences Corporation · Updated on 2024-06-03

60

Participants Needed

1

Research Sites

174 weeks

Total Duration

On this page

Sponsors

H

Hamilton Health Sciences Corporation

Lead Sponsor

A

AAAAI Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

TRADE Trial - Tree Nut Immunotherapy Route Development and Evaluation

Who Can Participate

Age: 1Year - 16Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Allergic to tree nut with baseline threshold of 444 mg protein or less
  • Provides consent, and where applicable, assent
  • Age between 1 and 16 years
Not Eligible

You will not qualify if you...

  • History of anaphylaxis to tree nut causing shock, syncope, or intubation
  • Eosinophilic or other inflammatory gastrointestinal disease within the past 2 years
  • Severe (GINA severity class 5) or uncontrolled asthma, including exacerbation within past 6 months
  • Use of biologics, other food immunotherapy, or experimental treatment in past 6 months
  • Ongoing severe allergic diseases preventing discontinuation of antihistamines for 7 days prior to assessment visits
  • Pregnancy or significant medical conditions such as liver, kidney, gastrointestinal, cardiovascular, hematologic, or pulmonary disease
  • Allergy to the oat-based placebo
  • Any condition judged by local investigator to put participant at excessive risk for food allergic reactions

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

McMaster University Medical Centre

Hamilton, Ontario, Canada

Actively Recruiting

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Research Team

H

Heather Le

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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