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| Name | Class |
|---|---|
| AllerGen NCE Inc. | INDUSTRY |
| McMaster University | OTHER |
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The purpose of the study is to determine how a type of treatment for peanut allergy known as oral desensitization works in the immune system.
Objectives
Allergic reactions to peanuts and tree nuts account for the majority of fatal and near fatal food allergic reactions, and the only treatment is complete avoidance of peanut. Despite avoidance, the majority of peanut allergic people will accidently ingest peanut. OIT has been shown to desensitize peanut allergic subjects (Hofmann et al. 2009). This would protect patients who have no other treatment, and may even form the basis for true tolerance to peanut in the future.
Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Immunotherapy with placebo antihistamines | Experimental | 500 mg Peanut Protein with placebo antihistamines |
|
| Double Placebo | Placebo Comparator | Placebo (Oat flour) and placebo antihistamines |
|
| Oral Immunotherapy with H1 and H2 antihistamines | Active Comparator | 500 mg Peanut Protein with Dosage of desloratidine 5 ml po od (0.5mg/ml = 2.5 mg) and ranitidine be 5ml (15mg/ml=75 mg) po bid. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peanut protein | Procedure | 500 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse effects | Frequency and risk of adverse events, overall and stratified by organ system and severity | 6-12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Health related quality of life pre and post intervention | Pre and post OIT. | 6-12 months |
| Eliciting doses to oral food challenge | Patients will be challenged at the end of the treatment period with peanut at the end to determine the change from threshold that they are able to tolerate. |
| Measure | Description | Time Frame |
|---|---|---|
| Immunological changes/Mechanistic outcomes | Various mechanistic outcomes/biomarkers | 6-12 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan Waserman, ME | McMaster University | Principal Investigator |
| Susan Waserman, MD | McMaster University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McMaster University | Hamilton | Ontario | L8N 3Z5 | Canada |
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| ID | Term |
|---|---|
| D021183 | Peanut Hypersensitivity |
| ID | Term |
|---|---|
| D000074924 | Nut and Peanut Hypersensitivity |
| D005512 | Food Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
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| ID | Term |
|---|---|
| D006633 | Histamine Antagonists |
| C121345 | desloratadine |
| D011899 | Ranitidine |
| ID | Term |
|---|---|
| D018494 | Histamine Agents |
| D018377 | Neurotransmitter Agents |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
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| Oat flour | Procedure | 500 mg Oat flour |
|
| Antihistamine | Drug | Desloratidine 5 ml po od (0.5mg/ml = 2.5 mg) Ranitidine 5ml (15mg/ml=75 mg) po bid |
|
|
| 6-12 months |
| D007154 | Immune System Diseases |
| D020164 | Chemical Actions and Uses |
| D045505 | Physiological Effects of Drugs |
| D005663 | Furans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |