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Evaluation of Potential Allergenicity of New Wheat Varieties

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ClinicalTrials.gov Identifier: NCT02341040
Recruitment Status : Recruiting
First Posted : January 19, 2015
Last Update Posted : January 17, 2018
Monsanto Company, LLC
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:
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 IgE antibody reactivity to biotech and conventional wheat varieties.

Condition or disease
Food Allergy Wheat Allergy

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Potential Allergenicity of New Wheat Varieties
Study Start Date : November 2014
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : March 2018

Primary Outcome Measures :
  1. Evaluate whole wheat-specific IgE antibody [ Time Frame: ~2 weeks ]
    To determine the relationship between whole wheat-specific IgE

Secondary Outcome Measures :
  1. Relationship between IgE components and oral food challenge [ Time Frame: ~2 weeks ]
    , IgE to components Tri a 14, Tri a 19, and Tri a Aa_TI, and Oral Food Challenges outcomes.

  2. Cross-Reactivity [ Time Frame: ~1 month ]
    To assess cross-reactivity between wheat and grass allergens in wheat-allergic patients.

  3. Potential Allergenicity [ Time Frame: ~1 month ]
    To evaluate the potential allergenicity of putative wheat allergens.

  4. Monsanto Repository [ Time Frame: ~2 weeks ]
    To establish a serum repository at Monsanto of wheat-reactive allergic patients.

Biospecimen Retention:   Samples Without DNA
Subjects may opt to have extra blood drawn. This sample will be de-identified and sent to the sponsor, Monsanto, for future study that is yet to be determined.

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Ages Eligible for Study:   1 Year to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Pediatric and adult subjects between the ages of 1 (inclusive) to 21 years (inclusive) that have sensitivity to wheat

Inclusion Criteria:

  • 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: A) Recent (within one year) failed open OFC B) Positive DBPCFC to wheat at CHCO C) 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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

Contact: David Fleischer, MD 720-777-2575 david.fleischer@childrenscolorado.org
Contact: Hannah Gilbert, BS 720-777-2569 hannah.gilbert@childrenscolorado.org

United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Hannah Gilbert    720-777-2569    hannah.gilbert@childrenscolorado.org   
Sponsors and Collaborators
University of Colorado, Denver
Monsanto Company, LLC

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02341040     History of Changes
Other Study ID Numbers: 14-1416
UL1TR001082 ( U.S. NIH Grant/Contract )
First Posted: January 19, 2015    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018

Keywords provided by University of Colorado, Denver:
wheat allergy
food allergy

Additional relevant MeSH terms:
Food Hypersensitivity
Wheat Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate