FREoE Study
Introduction to FREoE Study and EoE Team
Our team has been fortunate to bring many advances to the field of pediatric EoE with over 60 peer reviewed publications. A focus on children, teens and families has always been at top of mind, with the development of the first and only patient/family validated outcome metrics called the PedsQLEoE module and the Pediatric Eosinophilic Esophagitis (EoE) Score (PEES™ v2.0).
We believe this clinical trial is an important step forward. There is increasing concern by the Food and Drug Administration, the American Academy of Pediatrics and within the field of Pediatric GI that food additives may be contributing to inflammation in the body. Our FREoE study seeks to determine whether food additives and preservatives many play a role in EoE. Overall, we look to provide either a dairy or dairy plus food additive removal diet that is healthy and manageable in everyone’s busy daily lives. We will have the unique ability to provide nutrition support and study enrollment remotely.
What Is the Clinical Study About?
Eosinophilic Esophagitis (EoE) is often a reaction to common food allergens. Removing dairy from the diet is successful in reducing or even eliminating symptoms in an estimated 30% of cases. Experts suggest that, in general, common food additives in the diet could be harmful to our health. Scientists have not tested the effects of food additives on EoE. We are interested in whether eliminating common food additives in addition to eliminating dairy from the diet will result in even better outcomes in EoE patients than just eliminating dairy alone.
The benefit of this trial is that your child will be evaluated by a pediatric dietician with expertise in EoE. We will partner with your local physician and care team.
Eligibility Criteria
If you are between the ages of 2-18 years old and have been diagnosed with Eosinophilic Esophagitis and meet the following criteria:
- You have not taken prednisone in the last 12 weeks
- You have not taken swallowed steroids (e.g. budesonide) in the last 8 weeks
- You have not had esophageal surgery
- You do not have Inflammatory Bowel Disease, Celiac Disease, or another gastrointestinal disorder
- You have access to the internet and phone service
- Your child or teen is currently under the care of a pediatric gastroenterologist in the United States
Study Design
Your child will be randomized (like the flip of a coin) to one of two treatment groups. One group will go on a dairy free diet. The other group will go on a dairy free and food additive free diet.
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 72 participants
Allocation: Randomized
Intervention Model Description: Randomized, prospective, parallel
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Food Additive Removal Diet for Pediatric Eosinophilic Esophagitis
For detailed information about this study, please see the trial registration in Clinical Trials.Gov
How it Works
If your doctor diagnosed your child with eosinophilic esophagitis based on the results of an endoscopy, and your child has not yet begun steroid therapy, then the FREoE Study might be a good fit.
Email Us
If you are interested in participating in the FREoE study, email EoEOrlando@nemours.org. Our study staff will contact you.
Is a Clinical Trial Right for You?
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about it.
To learn more about this study, you or your doctor may contact our research team directly at EoEOrlando@nemours.org.
For general information, visit Clinical Trials.