Back to resultsPeanut and Tree Nut Desensitization
Primary Purpose
Peanut Allergy, Tree Nut Allergy
Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Oral immunotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Peanut Allergy
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 .
Sites / Locations
- Hospital for Sick Children
- Montreal Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Active Comparator
Active Comparator
Arm Label
Control
Low-dose
High-dose
Arm Description
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
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
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
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) specigic 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
Measurement of peanut or tree nut (as appropriate) specigic 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
Measurement of peanut or tree nut (as appropriate) specigic IgG4 before, during and after the desensitization process
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
Change from baseline over the immunotherapy process of of DNA methylation levels
Measurement of DNA methylation levels before, during and after the desensitization process
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
Full Information
NCT ID
NCT03532360
First Posted
March 16, 2018
Last Updated
July 25, 2022
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators
Julia Upton, Hospital for Sick Children, University of Toronto
1. Study Identification
Unique Protocol Identification Number
NCT03532360
Brief Title
Peanut and Tree Nut Desensitization
Official Title
Peanut/Tree Nut Desensitization and Induction of Tolerance in Children
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 19, 2018 (Actual)
Primary Completion Date
January 2, 2024 (Anticipated)
Study Completion Date
January 2, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators
Julia Upton, Hospital for Sick Children, University of Toronto
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peanut Allergy, Tree Nut Allergy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
Participant
Masking Description
Participants will be randomized to one of three groups: a control group that will receive no treatment, a low-dose group and a high dose group. Participants in the latter two groups will be blinded as to what group they have been assigned
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
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
Arm Title
Low-dose
Arm Type
Active Comparator
Arm Description
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
Arm Title
High-dose
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Oral immunotherapy
Intervention Description
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
Primary Outcome Measure Information:
Title
Efficacy of desensitization in peanut/tree nut allergic patients as measured by blinded, placebo controlled oral food challenge
Description
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
Title
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
Description
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
Secondary Outcome Measure Information:
Title
Change from baseline over the immunotherapy process of peanut or tree nut (as appropriate) specigic IgE levels
Description
Measurement of peanut or tree nut (as appropriate) specigic IgE before, during and after the desensitization process
Time Frame
21 months
Title
Change from baseline over the immunotherapy process of peanut or tree nut (as appropriate) specigic IgA levels
Description
Measurement of peanut or tree nut (as appropriate) specigic IgA before, during and after the desensitization process
Time Frame
21 months
Title
Change from baseline over the immunotherapy process of peanut or tree nut (as appropriate) specigic IgG4 levels
Description
Measurement of peanut or tree nut (as appropriate) specigic IgG4 before, during and after the desensitization process
Time Frame
21 months
Title
Change from baseline over the immunotherapy process of mast cell activation as measured by CD63 expression
Description
Measurement of mast cell activation as measured by CD63 expression before, during and after the desensitization process
Time Frame
21 months
Title
Change from baseline over the immunotherapy process of of DNA methylation levels
Description
Measurement of DNA methylation levels before, during and after the desensitization process
Time Frame
21 months
Title
Change from baseline over the immunotherapy process of Regulatory T cell levels
Description
Measurement of Regulatory T cell levels, before, during and after the desensitization process
Time Frame
21 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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 .
Facility Information:
Facility Name
Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Facility Name
Montreal Children's Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
12. IPD Sharing Statement
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Peanut and Tree Nut Desensitization
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