Evaluation of Potential Allergenicity of New Wheat Varieties

NCT02341040 | Terminated

• 2 other identifiers: 14-1416UL1TR001082
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

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 immunoglobulin-e (IgE) antibody reactivity to biotech and conventional wheat varieties.

Conditions

Food Allergy; Wheat Allergy

Keywords

wheat allergy; food allergy; pediatric

Outcome Measures

Primary Outcomes (1)

• Determine the relationship between whole wheat-specific IgE and IgE to components

  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..

  ~2 weeks

Secondary Outcomes (4)

• Determine the relationship between IgE components and oral food challenge

  ~2 weeks

• Determine the Cross-Reactivity between wheat and grass allergens

  ~1 month

• Determine the Potential Allergenicity

  ~1 month

• Establish a Serum Repository

  ~2 weeks

Eligibility Criteria

• Age: 1 Year - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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

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:
• hospitalization in the past year for asthma, or
• 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
• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Monsanto Company, LLC: collaborator

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

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.

MeSH Terms

Conditions

Food Hypersensitivity; Wheat Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• David Fleischer, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2015
• First Posted: January 19, 2015
• Study Start: November 1, 2014
• Primary Completion: May 15, 2018
• Study Completion: May 15, 2018
• Last Updated: May 21, 2018

Record last verified: 2018-05

Locations

US (1)