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| Name | Class |
|---|---|
| North Carolina Agriculture & Technical State University | OTHER |
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This is a proof of concept study to determine the safety and allergenicity of hypoallergenic peanut product extract as compared to standard peanut extract in an adult population with known peanut allergy. This will be assessed by epicutaneous skin prick testing. The hypothesis is that subjects with previously diagnosed peanut allergy will have less epicutaneous reactions to the hypoallergenic peanut product extract.
Peanut allergic volunteers will be identified by positive skin prick test to peanut (peanut extract obtained from Greer laboratories). The peanut extract to be used is FDA approved and is routinely used in confirming a diagnosis of peanut allergy. Serum Total IgE and peanut-specific IgE will be measured for assessment of atopy in general and confirmation of Peanut allergy respectively. Only patients with positive skin test to peanut will enrolled into the study.
Allergic volunteers will be asked to abstain from taking any antihistamines (H1 or H2) during the 3 days prior to the skin testing.
Testing day
Physical Exams will be performed by a study physician. Procedures such as skin testing, vital signs, venipuncture, will be done by a study coordinator, qualified nurse or technical staff. Clinical labs (Serum IgE and Peanut-specific IgE) will be processed at Labcorp Inc in Burlington, NC.
Recording of Skin Test results: Skin test reactions will be traced onto clear cellophane tape from which measurements will be obtained. This tape will be affixed to a subject's visit record but not their personal medical record.
Excess samples remaining after completion of analyses for this study will be stored in the CEMALB Repository (IRB #05-2528) and all participants will be asked to sign the Repository consent form. Failure to consent to the repository will not result in exclusion from the main study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peanut allergic subjects |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epicutaneous skin prick testing | Other | Epicutaneous skin prick testing will be performed utilizing the following extracts:
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| Measure | Description | Time Frame |
|---|---|---|
| Size of wheal with epicutaneous testing using non-hypoallergenic extracts. | Size of wheal for hypoallergenic extracts will be measured. | 20 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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Thirty (30) adult subjects with history of peanut allergy, with or without asthma will be recruited. All participants will be adults ages 18-65. There will no gender or ethnic restrictions.
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| Name | Affiliation | Role |
|---|---|---|
| Michelle Hernandez, MD | University of North Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Environmental Medicine, Asthma and Lung Biology | Chapel Hill | North Carolina | 27516 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Yu, J; Hernandez, M; Li, H; Goktepe, I; Robinette, C; Auerbach, A; Peden, D; Ahmedna, M. Allergenicity of roasted peanuts treated with a non-human digestive protease. Food Research International 2015 March; 69: 341-47. doi:10.1016/j.foodres.2015.01.007 |
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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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Venipuncture for 30mL of blood taken for measurement of peanut IgE.
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| D007154 | Immune System Diseases |