Evaluation of Potential Allergenicity of New Soybean Varieties (Monsanto)

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.

Study Overview

• Status: Terminated
• Conditions: Soy Allergy
• Intervention / Treatment: Other: Oral food challenge

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Children's Hospital Colorado

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 40 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Study population will primarily be obtained through patients at National Jewish Health

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate soy-specific IgE antibody	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.	approximately 2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relationship between IgE, components and oral food challenge	To determine the relationship between whole soy-specific IgE, IgE to components Gly m 4, 5, and 6, and OFC outcomes.	approximately 2 weeks
Monsanto repository	To establish a serum repository at Monsanto of soy-reactive allergic patients	approximately 2 weeks

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: David Fleischer, MD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): May 15, 2018
• Study Completion (Actual): May 15, 2018

Study Registration Dates

• First Submitted: September 23, 2013
• First Submitted That Met QC Criteria: September 23, 2013
• First Posted (Estimate): September 25, 2013

Study Record Updates

• Last Update Posted (Actual): July 13, 2018
• Last Update Submitted That Met QC Criteria: July 11, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: adult; pediatric; food allergy; soy allergy
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity
• Other Study ID Numbers: 14-0097; Monsanto (Other Identifier: Monsanto)