Children's Hospital Colorado

Soy Allergy Research Study

Allergy and Immunology | February 22, 2016
Physician-diagnosed soy allergy. History of an allergic reaction or a positive blood or skin test to soy.

Purpose of study

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 IgE testing of the food 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 Thermo Fisher. 

Research details

Procedures include:

  • Pulmonary function testing
  • Skin prick test
  • Blood test
  • Survey

Study participation involves:

  • Screening Visit
  • Two day Food Challenge
  • Financial Compensation 

You will not be charged for any of the study procedures or office visits required for participation in the study.

If you join the study, you will come to Children’s Hospital Colorado for your first visit (called a “Screening Visit”).

If you are eligible, you will return to do another test called a Food Challenge, which will take place over two visits.

If you have had a recent reaction to soy, you may not have to complete this Food Challenge.

The Screening Visit will last around 2 hours and each Food Challenge Visit could last up to 6-8 hours.

Study procedures come at no cost to the family. Participants will be compensated for their participation.

Additional information

This study is sponsored by Monsanto Company.

An optional part of this study is to allow the sponsor to use some of the blood collected from you, if you are soy allergic, 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. 

Please contact the study coordinator Hannah Gilbert at 720-777-2569 or at