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| Name | Class |
|---|---|
| The Hospital for Sick Children | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No 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 | |
| Low-dose | Active Comparator | 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 |
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| High-dose | Active Comparator | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral immunotherapy | Other | 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 21 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 21 months |
| Change from baseline over the immunotherapy process of peanut or tree nut (as appropriate) specigic IgA levels |
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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:
Informed consent form signed by the parents or legal guardian
Exclusion criteria.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada | ||
| Montreal Children's Hospital |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 7, 2019 | Aug 9, 2019 | Prot_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 1, 2019 | Aug 9, 2019 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D021183 | Peanut Hypersensitivity |
| D021184 | Nut Hypersensitivity |
| ID | Term |
|---|---|
| D000074924 | Nut and Peanut Hypersensitivity |
| D005512 | Food Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
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| ID | Term |
|---|---|
| D007167 | Immunotherapy |
| ID | Term |
|---|---|
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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Randomized controlled trial
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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
Measurement of peanut or tree nut (as appropriate) specific IgA before, during and after the desensitization process |
| 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 | 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 | 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 | 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 | 21 months |
| Montreal |
| Quebec |
| H4A 3J1 |
| Canada |
| D007154 | Immune System Diseases |