Oral Immunotherapy for Peanut and Tree Nut Allergy

Recruiting in Palo Alto (17 mi)

+1 other location

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

No Placebo Group

Trial Summary

What is the purpose of this trial?

this study evaluates whether tolerance to peanuts and tree nuts can be induced in patients through a process of oral immunotherapy. Participants will be randomized into groups receiving oral immunotherapy and a control group that will receive no intervention

Eligibility Criteria

This trial is for individuals aged 2-40 with a history of immediate allergic reactions to peanuts or tree nuts, confirmed by skin tests and specific IgE blood tests. They must have had a reaction within 120 minutes of exposure and consent from parents/guardians if underage. It excludes those with unstable respiratory conditions, immune diseases, severe hypertension, on immunosuppressors or β-blockers.

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. 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).

Exclusion Criteria

You have breathing problems that are not under control or stable.

You have a serious form of cancer or immune system disease.

Patients receiving immunosuppressor therapy.

Participant Groups

The study is testing oral immunotherapy's ability to induce tolerance in patients allergic to peanuts and tree nuts. Participants are randomly divided into two groups: one receiving the therapy and another serving as a control group without any intervention.

Group I: Control Active Control 1 Intervention

Following randomization, this arm will receive no intervention. After twelve months, participants in this group will undergo a singe-blind, placebo-controlled oral food challenge

Group II: Low-dose Active Control 1 Intervention

Following randomization, participants in this group will receive escalating doses of the appropriate allergen, up to a dose of 30 mg. Once they attain that dose, they will maintain it for six months. At the end of this maintenance period, they will undergo a singe-blind, placebo-controlled oral food challenge

Group III: High-dose Active Control 1 Intervention

Following randomization, participants in this group will receive escalating doses of the appropriate allergen, up to a dose of 300 mg. Once they attain that dose, they will maintain it for six months. At the end of this maintenance period, they will undergo a singe-blind, placebo-controlled oral food challenge

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Montreal Children's Hospital Montreal, Canada

Hospital for Sick Children Toronto, Canada

Who Is Running the Clinical Trial?

McGill University Health Centre/Research Institute of the McGill University Health Centre Lead Sponsor

Julia Upton, Hospital for Sick Children, University of Toronto Collaborator

References