Evaluation of Potential Allergenicity of New Soybean Varieties (Monsanto)
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|ClinicalTrials.gov Identifier: NCT01950559|
Recruitment Status : Terminated (insufficient subjects recruited in allotted time)
First Posted : September 25, 2013
Last Update Posted : July 13, 2018
Food allergy is on the rise within the pediatric population. Having a 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 immunoglobulin-e (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 ImmunoCAP manufactured by the company, ThermoFisher.
Soybean is one of the eight allergy-inducing foods that are responsible for 90% of all food allergies. A part of the study is to allow the study Sponsor to use some of the blood sample collected from you to test if genetically-changed soy has more or less allergy producing factors. This is important to the Sponsor to test the safety of their genetically modified soy.
|Condition or disease||Intervention/treatment|
|Soy Allergy||Other: Oral food challenge|
|Study Type :||Observational|
|Actual Enrollment :||10 participants|
|Official Title:||Evaluation of Potential Allergenicity of New Soybean Varieties|
|Study Start Date :||September 2013|
|Actual Primary Completion Date :||May 15, 2018|
|Actual Study Completion Date :||May 15, 2018|
Subjects who are allergic to Soy
Subject allergy to soy is determined by an oral food challenge or history of positive soy food challenge.
Other: Oral food challenge
Oral food challenge to determine allergy to soy
- Evaluate soy-specific IgE antibody [ Time Frame: approximately 2 weeks ]To quantitatively and/or qualitatively evaluate the soy-specific IgE antibody reactivity to biotech and conventional soybean varieties using sera from clinically documented soybean-allergic subjects.
- Relationship between IgE, components and oral food challenge [ Time Frame: approximately 2 weeks ]To determine the relationship between whole soy-specific IgE, IgE to components Gly m 4, 5, and 6, and OFC outcomes.
- Monsanto repository [ Time Frame: approximately 2 weeks ]To establish a serum repository at Monsanto of soy-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): NCT01950559
|United States, Colorado|
|Children's Hospital Colorado|
|Aurora, Colorado, United States, 80045|
|Principal Investigator:||David Fleischer, MD||University of Colorado, Denver|