Peanut and Tree Nut Desensitization

Launched by MCGILL UNIVERSITY HEALTH CENTRE/RESEARCH INSTITUTE OF THE MCGILL UNIVERSITY HEALTH CENTRE · May 9, 2018

Keywords

ClinConnect Summary

This clinical trial is looking at a treatment called oral immunotherapy to see if it can help people with peanut and tree nut allergies build up a tolerance to these foods. The goal is to see if participants can safely consume small amounts of peanuts or tree nuts without having an allergic reaction. In this study, some participants will receive the oral immunotherapy treatment, while others will not receive any treatment at all (this is called a control group).

To be eligible for this trial, participants need to be between 2 and 40 years old and must have a history of allergic reactions to peanuts or tree nuts. This means they would have experienced symptoms like hives, swelling, or difficulty breathing after eating these foods. Participants will be closely monitored throughout the study, and parents or legal guardians will need to give their consent for those under 18. It's important to note that people with certain health conditions, like respiratory issues or severe heart problems, cannot take part in this trial. Overall, this study aims to find a safe way to help people with nut allergies feel more comfortable around these foods.

Gender

ALL

Eligibility criteria

• Inclusion criteria: Patients between 2 and 40 years of age who satisfy all the following criteria will be included:
• • A history suggestive of immediate allergy to peanut/tree nut . A convincing clinical history of an IgE mediated reaction to a specific food will be defined as a minimum of 2 mild signs/symptoms or 1 moderate or 1 severe sign/symptom that was likely IgE mediated and occurred within 120 minutes after ingestion or contact (or inhalation in the case of fish and shellfish). Reactions will be considered mild if they involve pruritus, urticaria, flushing, or rhinoconjunctivitis; moderate if they involve angioedema, throat tightness, gastrointestinal complaints, or breathing difficulties (other than wheeze); and severe if they involve wheeze, cyanosis, or circulatory collapse.(54-57)
• * The presence of at least one of the following confirmatory tests:
• • Positive SPT to peanut/tree nut or its proteins (weal diameter 3 mm larger than that of the normal saline control). The allergens used will be commercial extracts of peanut/tree nut (Omega Labs, Toronto, Ontario).
• • Detection of serum specific IgE (\>0.35 kU/L) to peanut/tree nut or any of its proteins, measured by fluorescence enzyme immunoassay (Phadia, CAP System, Uppsala, Sweden).
• • Positive oral challenge test to peanut/tree nut. Oral challenges will be performed with raw peanut/tree nut according to the recommendations of the position paper of the European Academy of Allergology and Clinical Immunology (58).
• • Informed consent form signed by the parents or legal guardian
• • Exclusion criteria.
• • Patients who are unstable from a respiratory point of view ..
• • Patients who present with intercurrent disease at the time of starting desensitization.
• • Non-IgE-mediated or non-immunological adverse reactions to nuts.
• • Malignant or immunopathological diseases and/or severe primary or secondary immune deficiencies.
• • Patients receiving immunosuppressor therapy
• • Patients receiving β-blockers (including topical formulations).
• • Associated diseases contraindicating the use of epinephrine: cardiovascular disease or severe hypertension.
• • Patients diagnosed with eosinophilic gastrointestinal disorder .