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The Utility of Food-Specific IgE Measured With the IMMULITE 2000 Assay to Predict Symptomatic Food Allergy
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.
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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|Eligible Ages||3 Years - 21 Years|
- - Age 3 to 21 years of either sex and any race - Physician-diagnosed food allergy orOR convincing clinical history of food allergy to milk, egg, and/or peanut AND a sSkin prick test positive to milk, egg, and/or peanut (diameter of wheal > 3 mm or greater than negative control) orOR a detectable serum food-specific IgE level (ImmunoCAP and/or IMMULITE > 0.35 kUA/L) to milk, egg, and/or peanut - If no history of clinical reactivity to milk, egg, or peanut, then a positive skin prick test to milk, egg, and/or peanut (diameter of wheal > 3 mm or greater than negative control) OR a detectable serum food-specific IgE level within the previous 4 months to milk, egg, and/or peanut - Written informed consent from parent/guardian and assent (when age appropriate).
- - Willingness to submit specimen for laboratory serum IgE testing
Exclusion Criteria:- Inability to discontinue antihistamines for skin prick testing and OFCs - Current allergy to placebo ingredient (oat flour) OR reaction to any dose of placebo at the qualifying OFC - FEV1 value <80% predicted or OR any clinical features of moderate or severe persistent asthma, as defined by the 2007 NHLBI guidelines table for classifying asthma baseline severity (Step 3 or above).
- - Use of , and >high medium daily doses of inhaled corticosteroids, as defined by the 2007 NHLBI guidelines inhaled corticosteroid dosing table (500500 μg/day fluticasone or equivalents for an adult) or a long acting beta-agonist (LABA) to control asthma.
- - Asthma requiring either: > 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 asthmaUse of steroid medications (IV, IM or oral) for asthma in the following manners: - history of daily oral steroid dosing for >1 month during the past year or - burst or ssteroid course/burst in the past 3 months or - >2 burst oral steroid courses/bursts in the past year - History of intubation due to allergies or asthma - Life-threatening allergic reaction (e.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|National Jewish Health|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Erwin Gelfand, MD|
|Principal Investigator Affiliation||National Jewish Health|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Overall Status||Active, not recruiting|
The disease, disorder, syndrome, illness, or injury that is being studied.
|Peanut Allergy, Milk Allergy, Egg Allergy|
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National Jewish Health
Denver, Colorado, 80206