TRADE Trial - Tree Nut Immunotherapy Route Development and Evaluation

Launched by HAMILTON HEALTH SCIENCES CORPORATION · Aug 26, 2022

Keywords

ClinConnect Summary

The TRADE Trial is a research study that is looking at new ways to help people with tree nut allergies. Specifically, it is testing two types of treatments: one where participants place a small amount of the allergen under their tongue (sublingual immunotherapy) and another that uses smaller doses of the allergen taken by mouth (oral immunotherapy). The goal is to see if these methods are safe and effective in helping people tolerate tree nuts better.

To take part in this trial, you must be allergic to tree nuts and have a specific level of sensitivity. You should also be between the ages of 1 and 16, and willing to give your consent or have a guardian consent for you. However, there are some reasons you might not be able to participate, such as having a history of severe allergic reactions to tree nuts or certain health conditions. If you join the study, you can expect to follow a specific schedule and undergo assessments to monitor your response to the treatment. This trial is currently recruiting participants, so if you or someone you know is interested, it’s a good idea to reach out for more information!

Gender

ALL

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:
• • 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