TRADE Trial - Tree Nut Immunotherapy Route Development and Evaluation

Hamilton Health Sciences (HHS)

Status: Enrolling

Conditions: Food Allergy; Tree Nut Allergy

Treatments: Other: Food

Study type: Interventional

Funder types: Other

Identifiers

NCT05521711

HAH-21-013

Details and patient eligibility

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 1 to 16 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 3 patient groups

Active low dose oral immunotherapy and Placebo sublingual immunotherapy

Experimental group

Treatment:

Other: Food

Placebo low dose oral immunotherapy and Active sublingual immunotherapy

Experimental group

Treatment:

Other: Food

Placebo low dose oral immunotherapy and Placebo sublingual immunotherapy

Experimental group

Treatment:

Other: Food