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

NCT ID: NCT01950533

Last Updated: 2020-10-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 102 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2017-03-29

Brief Summary

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.

Conditions

Peanut Allergy; Milk Allergy; Egg Allergy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Peanut allergic

Subjects allergic to peanuts by oral food challenge

Oral food challenge

Intervention Type: PROCEDURE

Confirmation of allergy to egg, milk and/or peanut through an oral food challenge or documentation of a positive oral food challenge.

Milk allergic

Subjects allergic to milk by oral food challenge

Oral food challenge

Intervention Type: PROCEDURE

Confirmation of allergy to egg, milk and/or peanut through an oral food challenge or documentation of a positive oral food challenge.

Egg allergic

Subjects allergic to egg by oral food challenge

Oral food challenge

Intervention Type: PROCEDURE

Confirmation of allergy to egg, milk and/or peanut through an oral food challenge or documentation of a positive oral food challenge.

Interventions

Oral food challenge

Confirmation of allergy to egg, milk and/or peanut through an oral food challenge or documentation of a positive oral food challenge.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Age 3 to 21 years of either sex and any race
• Physician-diagnosed food allergy or convincing clinical history of food allergy to milk, egg, and/or peanut AND a Skin 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 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 asthma
• Use 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 steroid 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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Jewish Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Erwin Gelfand, MD

Role: PRINCIPAL_INVESTIGATOR

National Jewish Health

Locations

National Jewish Health

Denver, Colorado, United States

Countries

United States

Other Identifiers

Siemens

Identifier Type: OTHER

Identifier Source: secondary_id

IMMULITE 2000

Identifier Type: -

Identifier Source: org_study_id