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RecruitingNCT05521711TRADEUpdated Jun 3, 2024

TRADE Trial - Tree Nut Immunotherapy Route Development and Evaluation

An interventional study of Food in Tree Nut Allergy and Food Allergy, sponsored by Hamilton Health Sciences Corporation. Recruiting at 1 site in Canada. Open to participants aged 1 Year to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-03.

Sponsored by Hamilton Health Sciences Corporation · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2023; still recruiting 3 years 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
1 Year to 16 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Tree Nut Allergy
  • Food Allergy

Keywords

  • Immunotherapy
  • Randomized Controlled Trial (RCT)
03

In context

Nut Hypersensitivity

32 studies on the registry are indexed under Nut Hypersensitivity; 9 are open to participants now.

This study's planned enrollment of 60 is above the median of 51 across 17 interventional studies indexed under Nut Hypersensitivity.

Browse Nut Hypersensitivity studies →

Lead sponsor

Hamilton Health Sciences Corporation is the lead sponsor of 241 studies on the registry; 37 are open to participants now.

Browse Hamilton Health Sciences Corporation studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 16 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Active low dose oral immunotherapy and Placebo sublingual immunotherapy

    Other: Food

  • Experimental
    Placebo low dose oral immunotherapy and Active sublingual immunotherapy

    Other: Food

  • Experimental
    Placebo low dose oral immunotherapy and Placebo sublingual immunotherapy

    Other: Food

Interventions

  • OtherFood

    Commercially available powders or liquids

06

What researchers measure

Primary outcomes

  1. Eliciting dose thresholds to food challenge

    Time frame: 1 year

Secondary outcomes

  1. Quality of life

    Food allergy quality of life questionnaire

    Time frame: 1 Year

07

Study locations

1 of 1 sites recruiting
  • McMaster University Medical Centre
    Hamilton, Ontario, Canada
    • Heather Le · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — Will consider on a case by case basis.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Sep 2023 (actual). Primary completion is estimated for Nov 2026, 38 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 26, 2022
First posted
Aug 30, 2022
StartActual
Sep 1, 2023
Primary completionEst.
Nov 1, 2026
CompletionEst.
Jan 1, 2027
Last update
Jun 3, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05521711
Lead sponsor
Hamilton Health Sciences Corporation
Collaborators
AAAAI Foundation
Responsible party
Sponsor
First posted
Aug 30, 2022
Start date
Sep 1, 2023
Primary completion
Nov 1, 2026 (estimated)
Completion
Jan 1, 2027 (estimated)
Last update
Jun 3, 2024

Study contacts

Heather Le
Contact
lehea@hhsc.ca
905-521-2100 ext. 75153
Derek Chu, MD PhD FRCPC
principal investigator · Hamilton Health Sciences & McMaster University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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