Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| Siemens | Other Identifier | Siemens |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Food allergy is on the rise within the pediatric population. Having food allergy can cause medical, nutritional and psychological issues in those who suffer with it. Although making the appropriate diagnosis of food allergy is very important, properly diagnosing food allergy has been a challenge. Skin prick testing and food-specific IgE testing of the blood can give positive results that are false. Currently, Oral Food Challenges are the best way to diagnose a food allergy. Unfortunately, Oral Food Challenges are time consuming and may not be readily available to suspected food allergy sufferers. This study is designed to examine the effectiveness of an allergy-detecting blood test called IMMULITE 2000 manufactured by the study sponsor, Siemens.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peanut allergic | Subjects allergic to peanuts by oral food challenge |
| |
| Milk allergic | Subjects allergic to milk by oral food challenge |
| |
| Egg allergic | Subjects allergic to egg by oral food challenge |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral food challenge | Procedure | Confirmation of allergy to egg, milk and/or peanut through an oral food challenge or documentation of a positive oral food challenge. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relationship between food specific IgEs | To determine the relationship between food-specific IgE to whole proteins of milk, egg, and peanut using the IMMULITE 2000 assay and OFC outcomes. | approximately 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Logisitic regression analyses on data | To compare the results of logistic regression analyses using the IMMULITE 2000 assay and food challenge outcome data to data obtained in parallel using the ImmunoCAP assay for food-specific IgE antibodies. | approximately 2 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
> 1 hospitalization in the past year for asthma or > 1 ER visit in the past 6 months for asthma
History of intubation due to allergies or asthma
Use of steroid medications (IV, IM or oral) for asthma in the following manners:
History of intubation due to allergies or asthma
Life-threatening allergic reaction (e.gi.e., respiratory compromise, hypoxia, hypotension, use of epinephrine) to study food(s) (e.g., milk, egg, and/or peanut) within last 1 year
Diagnosis of active eosinophilic gastrointestinal disease in the past year
Severe or poorly controlled atopic dermatitis, as assessed by a three-item severity (TIS) score of 6 or greater (see Appendix I)
Use of omalizumab or other non-traditional forms of allergen immunotherapy (e.g., oral or sublingual), immunomodulatory therapy (not including corticosteroids), or biologic therapy within the past year
Uncontrolled hypertension
Any use of β-blockers (oral), angiotensin-converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARB) or calcium channel blockers
Other significant medical conditions (e.g., liver, gastrointestinal, kidney, cardiovascular, pulmonary disease, or blood disorders), which, in the opinion of the Investigator, make the subject unsuitable for induction of food reactions
Pregnancy
Not provided
Not provided
Study population will be primarily obtained from the pediatric clinic at National Jewish Health from those suspected of egg, milk and/or peanut food allergy.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Erwin Gelfand, MD | National Jewish Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Jewish Health | Denver | Colorado | 80206 | United States |
Not provided
| ID | Term |
|---|---|
| D021183 | Peanut Hypersensitivity |
| D016269 | Milk Hypersensitivity |
| D021181 | Egg Hypersensitivity |
| D005512 | Food Hypersensitivity |
| ID | Term |
|---|---|
| D000074924 | Nut and Peanut Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided