An interventional study of Oral immunotherapy in Peanut Allergy and Tree Nut Allergy, sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre. Completed at 2 sites in Canada. Open to participants aged 2 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre · Not applicable, Interventional, and Treatment
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
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
166 studies on the registry are indexed under Peanut Hypersensitivity; 27 are open to participants now.
This study's enrollment of 51 is close to the median of 50 across 127 interventional studies indexed under Peanut Hypersensitivity.
Browse Peanut Hypersensitivity studies →McGill University Health Centre/Research Institute of the McGill University Health Centre is the lead sponsor of 421 studies on the registry; 105 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion criteria: Patients between 2 and 40 years of age who satisfy all the following criteria will be included:
The presence of at least one of the following confirmatory tests:
Exclusion criteria.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Other: 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
Other: Oral immunotherapy
Starting from a very low level and over a period of several months, participants receive escalating doses of the food to which they are allergic
Efficacy of desensitization in peanut/tree nut allergic patients as measured by blinded, placebo controlled oral food challenge
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
Time frame: 21 months
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
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
Time frame: 21 months
Change from baseline over the immunotherapy process of peanut or tree nut (as appropriate) specigic IgE levels
Measurement of peanut or tree nut (as appropriate) specific IgE before, during and after the desensitization process
Time frame: 21 months
Change from baseline over the immunotherapy process of peanut or tree nut (as appropriate) specigic IgA levels
Measurement of peanut or tree nut (as appropriate) specific IgA before, during and after the desensitization process
Time frame: 21 months
Change from baseline over the immunotherapy process of peanut or tree nut (as appropriate) specigic IgG4 levels
Measurement of peanut or tree nut (as appropriate) specific IgG4 before, during and after the desensitization process
Time frame: 21 months
Change from baseline over the immunotherapy process of mast cell activation as measured by CD63 expression
Measurement of mast cell activation as measured by CD63 expression before, during and after the desensitization process
Time frame: 21 months
Change from baseline over the immunotherapy process of of DNA methylation levels
Measurement of DNA methylation levels before, during and after the desensitization process
Time frame: 21 months
Change from baseline over the immunotherapy process of Regulatory T cell levels
Measurement of Regulatory T cell levels, before, during and after the desensitization process
Time frame: 21 months
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Feb 2018 to primary completion in Jun 2025, 87 months.
Of 20 interventional studies with no phase under Peanut Hypersensitivity, half reached primary completion within 62 months of starting (the median), counting those still running; a quarter within 31 and three quarters within 66. This study's 87 months is above that.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 8, 2026: primary completion Jun 2024 → Jun 2025 and completion Dec 2027 → Jun 2025.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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McGill University Health Centre/Research Institute of the McGill University Health Centre →