Peanut and Tree Nut Desensitization

Not Applicable

Active, not recruiting

• Conditions: Tree Nut Allergy; Peanut Allergy
• Interventions: Other: Oral immunotherapy

• Registration Number: NCT03532360
• Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Brief Summary

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

Detailed Description

The investigators are proposing to initiate a study assessing a common desensitization protocol for peanut/tree nut allergy. This study would enable the investigators to better determine the potential benefit of desensitization in individuals with peanut/tree nut allergy.

More specifically, the investigators will address the following research objectives:

Objectives A. To develop a protocols for peanut/tree nut desensitization with high (300mg) and low (30mg maintenance dose).

B. To determine the rate of desensitization to peanut/tree nut. C. To characterize predictors of successful desensitization. D. To characterize molecular mechanisms involved in the process of desensitization

These objectives will be evaluated through a randomized controlled trial

Study Timeline

• Study Start: 2018-02-19
• Study First Submitted: 2018-03-16
• Study First Submitted QC: 2018-05-09
• Study First Posted: 2018-05-22
• Primary Completion: 2024-06-26
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-04
• Last Update Posted: 2025-02-06
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High-dose	Oral immunotherapy	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
Low-dose	Oral immunotherapy	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

Primary Outcome Measures

Name	Time	Method
Efficacy of desensitization in peanut/tree nut allergic patients as measured by blinded, placebo controlled oral food challenge	21 months	Comparison of participants randomized to treatments arms who achieve peanut/tree nut desensitization compared to participants randomized to the control groups. This is measured by whether a participant is able to tolerate a total dose of 4172 mg crushed peanut or tree nut during an oral food challenge
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	21 months	Participants in the 30 mg arm will be compared to those in the 300 mg in terms of dose tolerated at post-immunotherapy blinded, placebo-controlled oral food challenge, as well as side effects experienced during immunotherapy

Secondary Outcome Measures

Name	Time	Method
Change from baseline over the immunotherapy process of peanut or tree nut (as appropriate) specigic IgE levels	21 months	Measurement of peanut or tree nut (as appropriate) specific IgE before, during and after the desensitization process
Change from baseline over the immunotherapy process of peanut or tree nut (as appropriate) specigic IgA levels	21 months	Measurement of peanut or tree nut (as appropriate) specific IgA before, during and after the desensitization process
Change from baseline over the immunotherapy process of peanut or tree nut (as appropriate) specigic IgG4 levels	21 months	Measurement of peanut or tree nut (as appropriate) specific IgG4 before, during and after the desensitization process
Change from baseline over the immunotherapy process of mast cell activation as measured by CD63 expression	21 months	Measurement of mast cell activation as measured by CD63 expression before, during and after the desensitization process
Change from baseline over the immunotherapy process of of DNA methylation levels	21 months	Measurement of DNA methylation levels before, during and after the desensitization process
Change from baseline over the immunotherapy process of Regulatory T cell levels	21 months	Measurement of Regulatory T cell levels, before, during and after the desensitization process

Trial Locations

Locations (2)

Montreal Children's Hospital; 🇨🇦 Montreal, Quebec, Canada

Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada