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Pilot study to assess the effect of oral immunotherapy on specific Immunoglobulin E (IgE) levels and antigen consumption in two distinct food allergies.
In subjects with mammalian meat allergy, the effect of daily oral cow's milk on immune parameters and desensitization will be assessed. Similarly, in subjects with a peanut allergy the effects of low dose peanut flour will be assessed and comparisons between two distinct food allergies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cow's milk for alpha-gal allergics | Experimental | daily consumption of cow's milk |
|
| Peanut powder | Experimental | peanut oral immunotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cow's milk | Dietary Supplement | daily consumption of cow's milk |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The Level of Allergen Consumed Post-oral Immunotherapy | consumption of cow's milk or peanut flour at open challenge. This is a single time-point assessment; not measured repeatedly. | Following 36 months of maintenance oral immunotherapy, participants completed an open challenge at month 37 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Scott Commins, MD | University of Virginia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia | Charlottesville | Virginia | 22908 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25823600 | Derived | Wisniewski JA, Commins SP, Agrawal R, Hulse KE, Yu MD, Cronin J, Heymann PW, Pomes A, Platts-Mills TA, Workman L, Woodfolk JA. Analysis of cytokine production by peanut-reactive T cells identifies residual Th2 effectors in highly allergic children who received peanut oral immunotherapy. Clin Exp Allergy. 2015 Jul;45(7):1201-13. doi: 10.1111/cea.12537. |
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Due to changes in funding structure, the study was unable to be completed with the designed number of participants and was therefore closed to enrollment
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| ID | Title | Description |
|---|---|---|
| FG000 | Cow's Milk for Alpha-gal Allergics | daily consumption of cow's milk cow's milk: daily consumption of cow's milk |
| FG001 | Peanut Powder | peanut oral immunotherapy peanut powder: peanut oral immunotherapy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cow's Milk for Alpha-gal Allergics | daily consumption of cow's milk cow's milk: daily consumption of cow's milk |
| BG001 | Peanut Powder | peanut oral immunotherapy peanut powder: peanut oral immunotherapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Level of Allergen Consumed Post-oral Immunotherapy | consumption of cow's milk or peanut flour at open challenge. This is a single time-point assessment; not measured repeatedly. | Posted | Mean | Standard Deviation | milligrams | Following 36 months of maintenance oral immunotherapy, participants completed an open challenge at month 37 |
|
3 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cow's Milk for Alpha-gal Allergics | daily consumption of cow's milk cow's milk: daily consumption of cow's milk |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| food intolerance | Gastrointestinal disorders | Non-systematic Assessment | difficulty tolerating daily dosing |
Unblinded and without placebo control
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Department of Medicine and Pediatrics | University of Virginia | 434.924.0000 | spc7w@virginia.edu |
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| ID | Term |
|---|---|
| D005512 | Food Hypersensitivity |
| ID | Term |
|---|---|
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D008892 | Milk |
| ID | Term |
|---|---|
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D003611 | Dairy Products |
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| peanut powder |
| Dietary Supplement |
peanut oral immunotherapy |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 7 |
| 1 |
| 7 |
| EG001 | Peanut Powder | peanut oral immunotherapy peanut powder: peanut oral immunotherapy | 0 | 17 | 3 | 17 |
|
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| D005502 |
| Food |
| D019602 | Food and Beverages |