TRADE Trial - Tree Nut Immunotherapy Route Development and Evaluation

Food Allergy Clinical Trial

— TRADE  

Official title:

TRADE Trial - Tree Nut Immunotherapy Route Development and Evaluation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05521711
• Other study ID #: HAH-21-013
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: January 1, 2027

Study information

• Verified date: August 2022
• Source: Hamilton Health Sciences Corporation
• Contact: Sue Beaudin, CCRA
• Phone: 905-525-9140
• Email: beaudins[@]mcmaster.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: January 1, 2027
• Est. primary completion date: November 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 16 Years

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

Related Conditions & MeSH terms

• Food Allergy
• Food Hypersensitivity
• Hypersensitivity
• Nut Hypersensitivity
• Tree Nut Allergy

Intervention

Other:
• Food
Commercially available powders or liquids

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation	AAAAI Foundation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eliciting dose thresholds to food challenge		1 year
Secondary	Quality of life	Food allergy quality of life questionnaire	1 Year