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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jennifer Brandorff, National Jewish Health
ClinicalTrials.gov Identifier:
NCT01950533
First received: September 23, 2013
Last updated: March 27, 2017
Last verified: March 2017
  Purpose
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.

Condition Intervention
Peanut Allergy Milk Allergy Egg Allergy Procedure: Oral food challenge

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Utility of Food-Specific IgE Measured With the IMMULITE 2000 Assay to Predict Symptomatic Food Allergy

Resource links provided by NLM:


Further study details as provided by Jennifer Brandorff, National Jewish Health:

Primary Outcome Measures:
  • Relationship between food specific IgEs [ Time Frame: approximately 2 weeks ]
    To determine the relationship between food-specific IgE to whole proteins of milk, egg, and peanut using the IMMULITE 2000 assay and OFC outcomes.


Secondary Outcome Measures:
  • Logisitic regression analyses on data [ Time Frame: approximately 2 weeks ]
    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.


Enrollment: 102
Study Start Date: September 2013
Estimated Study Completion Date: September 2019
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Peanut allergic
Subjects allergic to peanuts by oral food challenge
Procedure: 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.
Milk allergic
Subjects allergic to milk by oral food challenge
Procedure: 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.
Egg allergic
Subjects allergic to egg by oral food challenge
Procedure: 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.

  Eligibility

Ages Eligible for Study:   3 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01950533

Locations
United States, Colorado
National Jewish Health
Denver, Colorado, United States, 80206
Sponsors and Collaborators
National Jewish Health
Investigators
Principal Investigator: Erwin Gelfand, MD National Jewish Health
  More Information

Responsible Party: Jennifer Brandorff, Manager, Clinical Research Services, Regulatory, National Jewish Health
ClinicalTrials.gov Identifier: NCT01950533     History of Changes
Other Study ID Numbers: IMMULITE 2000
Siemens ( Other Identifier: Siemens )
Study First Received: September 23, 2013
Last Updated: March 27, 2017

Keywords provided by Jennifer Brandorff, National Jewish Health:
Peanut allergy
Milk allergy
Egg allergy
Pediatric
Adult
Food allergy

Additional relevant MeSH terms:
Hypersensitivity
Food Hypersensitivity
Peanut Hypersensitivity
Milk Hypersensitivity
Egg Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate

ClinicalTrials.gov processed this record on June 27, 2017