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Peanut Allergy | The Utility of Food-Specific IgE Measured With the IMMULITE 2000 Assay to Predict Symptomatic Food Allergy

Peanut Allergy research study

What is the primary objective of this study?

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.

Who is eligible to participate?

Inclusion Criteria: - 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)., at the time of entry into the study - 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.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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Peanut Allergy

Milk Allergy

Egg Allergy

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Procedure:Oral food challengeConfirmation of allergy to egg, milk and/or peanut through an oral food challenge or documentation of a positive oral food challenge.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Peanut allergicSubjects allergic to peanuts by oral food challenge

Milk allergicSubjects allergic to milk by oral food challenge

Egg allergicSubjects allergic to egg by oral food challenge

Study Status

Active, not recruiting

Start Date: September 2013

Completed Date: September 2019

Phase:

Type: Observational

Design:

Primary Outcome: Relationship between food specific IgEs

Secondary Outcome: Logisitic regression analyses on data

Study sponsors, principal investigator, and references

Principal Investigator: Erwin Gelfand, MD

Lead Sponsor: National Jewish Health

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01950533

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