Recruiting NCT05521711
TRADE Trial - Tree Nut Immunotherapy Route Development and Evaluation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Food.
- Who it may be relevant to
- Registry conditions: Tree Nut Allergy, Food Allergy. Basic parameters: 1 year — 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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.
Interventions
- Other Food
Commercially available powders or liquids
Primary outcome measures
- Eliciting dose thresholds to food challenge [Time frame: 1 year]
Secondary outcome measures (1)
- Quality of life [Time frame: 1 Year]
Eligibility criteria
Inclusion criteria
- Allergic to tree nut with baseline threshold of 444 mg protein or less and provides consent, and where applicable, assent.
Exclusion criteria
- History of anaphylaxis to tree nut severe enough to cause 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 other allergic diseases severe enough to preclude discontinuing antihistamines for 7 days prior to assessment visits
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- McMaster University Medical Centre — Hamilton
Identifiers
NCT: NCT05521711 · HAH-21-013