Evaluation of Potential Allergenicity of New Wheat Varieties
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|ClinicalTrials.gov Identifier: NCT02341040|
Recruitment Status : Terminated (insufficient subjects recruited in allotted time)
First Posted : January 19, 2015
Last Update Posted : May 21, 2018
|Condition or disease|
|Food Allergy Wheat Allergy|
|Study Type :||Observational|
|Actual Enrollment :||5 participants|
|Official Title:||Evaluation of Potential Allergenicity of New Wheat Varieties|
|Study Start Date :||November 2014|
|Actual Primary Completion Date :||May 15, 2018|
|Actual Study Completion Date :||May 15, 2018|
- Determine the relationship between whole wheat-specific IgE and IgE to components [ Time Frame: ~2 weeks ]Logistic regression analyses will be performed to establish diagnostic decision pointsindicating a high likelihood of symptomatic food allergy to wheat, thus potentiallypreventing unnecessary food challenges for patients with wheat allergy..
- Determine the relationship between IgE components and oral food challenge [ Time Frame: ~2 weeks ]The investigators will evaluate IgE to components Tri a 14, Tri a 19, and Tri a Aa_TI, and Oral Food Challenges outcomes.
- Determine the Cross-Reactivity between wheat and grass allergens [ Time Frame: ~1 month ]To assess cross-reactivity between wheat and grass allergens in wheat-allergic patients.
- Determine the Potential Allergenicity [ Time Frame: ~1 month ]To evaluate the potential allergenicity of putative wheat allergens.
- Establish a Serum Repository [ Time Frame: ~2 weeks ]To establish a serum repository at Monsanto of wheat-reactive allergic patients.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02341040
|United States, Colorado|
|Children's Hospital Colorado|
|Aurora, Colorado, United States, 80045|
|Principal Investigator:||David Fleischer, MD||University of Colorado, Denver|