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Evaluation of Potential Allergenicity of New Soybean Varieties (Monsanto)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01950559
Recruitment Status : Terminated (insufficient subjects recruited in allotted time)
First Posted : September 25, 2013
Last Update Posted : July 13, 2018
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:

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

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Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Monsanto repository [ Time Frame: approximately 2 weeks ]
    To establish a serum repository at Monsanto of soy-reactive allergic patients


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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Months to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Study population will primarily be obtained through patients at National Jewish Health
Criteria

Inclusion Criteria:

  • Age 6 months to 40 years of any sex and any race
  • A convincing history of allergic reaction to soybean and a positive ImmunoCAP (>0.35 kU/L) and/or a positive skin prick test to soy. Subjects should have ImmunoCAP repeated (if not done within the last 6 months) at National Jewish Health.
  • One of the following:

A) Recent (within one year) failed open OFC B) Positive DBPCFC to soy at NJH; or C) Recent (within one year) exposure to soybean resulting in immediate IgE-mediated allergic symptoms (within 2 hours of ingestion; symptoms such as urticaria, angioedema, congestion, rhinorrhea, wheezing).

  • 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
  • Current allergy to placebo ingredient (oat flour) OR reaction to any dose of placebo at the qualifying OFC
  • 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 severity (Step 3 or above), and greater than high daily doses of inhaled corticosteroids, as defined by the 2007 NHLBI guidelines inhaled corticosteroid dosing table (500 μg fluticasone or equivalents for an adult)
  • Asthma requiring either:

> 1 hospitalization in the past year for asthma or > 1 ER visit in the past 6 months for asthma

  • History of intubation due to allergies or asthma
  • Life-threatening allergic reaction (i.e. respiratory compromise, hypoxia, hypotension) to food(s) within last 1 year
  • Diagnosis of active eosinophilic gastrointestinal disease in the past year
  • Severe or poorly controlled atopic dermatitis
  • Use of omalizumab or other non-traditional forms of allergen immunotherapy (e.g., oral or sublingual), immunomodulatory therapy (not including corticosteroids), or biologic therapy within the past year
  • Uncontrolled hypertension
  • Any use of β-blockers (oral), angiotensin-converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARB) or calcium channel blockers
  • Other significant medical conditions (e.g., liver, gastrointestinal, kidney, cardiovascular, pulmonary disease, or blood disorders), which, in the opinion of the Investigator, make the subject unsuitable for induction of food reactions
  • Pregnancy

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): NCT01950559


Locations
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United States, Colorado
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: David Fleischer, MD University of Colorado, Denver

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01950559    
Other Study ID Numbers: 14-0097
Monsanto ( Other Identifier: Monsanto )
First Posted: September 25, 2013    Key Record Dates
Last Update Posted: July 13, 2018
Last Verified: July 2018
Keywords provided by University of Colorado, Denver:
soy allergy
food allergy
pediatric
adult
Additional relevant MeSH terms:
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Hypersensitivity
Immune System Diseases