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Immunotherapy

Oral Immunotherapy for Peanut and Tree Nut Allergy

N/A

Waitlist Available

Research Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 21 months

Awards & highlights

Study Summary

This trial is testing whether people can be trained to be less allergic to peanuts and tree nuts by gradually exposing them to increasing amounts.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects may include itching, hives, flushing, nasal/eye irritation (mild), swelling around the eyes/throat (moderate), gastrointestinal issues or breathing difficulties excluding wheezing (moderate), wheezing or circulatory collapse (severe).

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 21 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~21 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 21 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Comparison of efficacy of 30 mg dose versus 300 mg dose in inducing desensitization to peanut or tree nut as measured by blinded, placebo controlled oral food challenge

Efficacy of desensitization in peanut/tree nut allergic patients as measured by blinded, placebo controlled oral food challenge

Secondary outcome measures

Change from baseline over the immunotherapy process of Regulatory T cell levels

Change from baseline over the immunotherapy process of mast cell activation as measured by CD63 expression

Change from baseline over the immunotherapy process of of DNA methylation levels

+3 more

Trial Design

3Treatment groups

Active Control

Group I: ControlActive Control1 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-doseActive Control1 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-doseActive Control1 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

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

447 Previous Clinical Trials

159,702 Total Patients Enrolled

Julia Upton, Hospital for Sick Children, University of TorontoUNKNOWN

Media Library

Oral immunotherapy (Immunotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT03532360 — N/A

Peanut Allergy Research Study Groups: Control, Low-dose, High-dose

Peanut Allergy Clinical Trial 2023: Oral immunotherapy Highlights & Side Effects. Trial Name: NCT03532360 — N/A

Oral immunotherapy (Immunotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03532360 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this experiment accept elderly participants who are over 80?

"Based on the eligibility criteria, this study is recruiting individuals that are aged 2 or more years and younger than 40."

Answered by AI

Is it possible to participate in this clinical research?

"To qualify for this trial, individuals must have a documented history of peanut allergies and be between the ages of 2 and 40. The team is seeking to recruit approximately 50 candidates."

Answered by AI

What objectives are researchers hoping to achieve with this trial?

"This trial, which will last for 21 months, has a primary objective of assessing the efficacy of desensitization in peanut/tree nut allergic patients with blinded placebo controlled oral food challenge. Secondary objectives include measuring mast cell activation by CD63 expression as well as evaluating specific IgA levels and Regulatory T Cell levels before, during, and after therapeutic desensitisation."

Answered by AI

Is there currently an opportunity for individuals to enter the trial?

"As indicated on clinicaltrials.gov, this particular medical trial is not currently enrolling any more individuals; the study was initially posted in February 2018 and amended for the last time on July 25th 2022. Nonetheless, 259 other studies are actively accepting patients at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Peanut and Tree Nut Desensitization

Bruce Mazer 2018. "Peanut and Tree Nut Desensitization". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03532360.