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Recruiting

NCT Number: NCT05521711

TRADE Trial - Tree Nut Immunotherapy Route Development and Evaluation

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.

Recruiting

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Key information

Age range

1 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McMaster University Medical Centre

Hamilton, Ontario, Canada

Location status: Recruiting

Location contact

Heather Le

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Food

Other

Commercially available powders or liquids

Primary outcomes

  1. Eliciting dose thresholds to food challenge

    Time frame: 1 year

Secondary outcomes

  1. Quality of life

    Time frame: 1 Year

    Food allergy quality of life questionnaire

Study contacts

Contact information is provided by the study sponsor or research team.

Heather Le

CONTACT

[email protected]

905-521-2100 ext. 75153

Sponsors and collaborators

Lead sponsor

Hamilton Health Sciences Corporation

Other

Collaborators

  • AAAAI Foundation

Registry information

Acronym: TRADE

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Aug 30, 2022
Registry last updated
Jun 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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