Evaluation of Potential Allergenicity of New Wheat Varieties

Stopped early

Conditions studied: Food Allergy, Wheat Allergy

In brief

The goal of the study is to determine accurate blood test levels that can predict whether or not subjects are truly allergic to certain foods. In this study, subjects that are clinically documented to be wheat-allergic will participate in a double blind oral food challenge. Blood will be collected from the subject to evaluate the potential allergenicity of proteins introduced into genetically modified crops and evaluate wheat-specific immunoglobulin-e (IgE) antibody reactivity to biotech and conventional wheat varieties.

Key facts

Study ID

NCT02341040

Run by

University of Colorado, Denver

People needed

5

Starts

2014-11-01

Expected to finish

2018-05-15

Last updated by the study team

2018-05-21

Who can join

Age: 1 and older, up to 21. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age 1 year to 21 years of any sex and any race
• Physician-diagnosed food allergy to wheat with convincing clinical history of food allergy to wheat AND a skin prick test positive to wheat (diameter of wheal 3 mm or greater than negative control) or a detectable serum food-specific IgE level (ImmunoCAP > 0.35 kUA/L) to wheat within the previous 12 months or at the time of entry into the study
• If no history of clinical reactivity to wheat, then a positive skin prick test to wheat (diameter of wheal 3 mm or greater than negative control) OR a detectable serum food-specific IgE level to wheat within the previous 12 months or at the time of entry into the study
• Patients who meet any of the following criteria are eligible for enrollment as study participants if they meet all other criteria, but will not undergo a DBPCFC:
• Recent (within one year) failed open OFC
• Positive DBPCFC to wheat at CHCO
• Recent (within one year) exposure to wheat resulting in immediate IgE-mediated allergic symptoms (within 2 hours of ingestion; symptoms such as urticaria, angioedema, congestion, rhinorrhea, wheezing, respiratory compromise, hypoxia, hypotension)
• Written informed consent from parent/guardian and assent (when age appropriate).
• Willingness to submit specimen for laboratory serum IgE testing
• Willingness to submit lab specimen for ELISA testing

You may not qualify if…

• Inability to discontinue antihistamines for skin prick testing and OFCs
• 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, at the time of entry into the study
• Use of >500 μg/day fluticasone or equivalent
• Asthma requiring either:
• 1 hospitalization in the past year for asthma, or
• 1 ER visit in the past 6 months for 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
• steroid course/burst in the past 3 months (except for steroid dosing used in the treatment of an allergic reaction during the DBPCFC), or
• 2 steroid courses/bursts in the past year.
• History of intubation due to allergies or asthma
• Diagnosis of active eosinophilic gastrointestinal disease in the past year
• Severe atopic dermatitis, as assessed by a Three-Item Severity Score of 6 or greater

Where it is running

• Children's Hospital Colorado — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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