Skip to main content

As of January 12, 2016 Microsoft announced the end of support for IE10, IE9 and IE8. Mainstream support for IE11 officially ended in November of 2020 as Microsoft announced they will drop support across Microsoft 365 apps in August of 2021.

Please consider using an alternative browser such as Chrome, Firefox, or Safari.

FREoE Study: A National Online Dietary Clinical Trial

pretty girl holding red apple over yellow studio background
ABOUT FREoE

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.

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.

sign up
Email Us

If you and your child are interested in participating in the FREoE Study, email EoEResearchers@nemours.org. Our study staff will contact you.

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
  • Estimated Study Completion Date December 31, 2021

For detailed information about this study, please see the trial registration in Clinical Trials.Gov

young children piled up in a pyramid at the park smiling
group of teens in a circle smiling looking down

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

Our EoE Team is Ready

Hello and welcome to our Food Additive Removal Trial for Eosinophilic Esophagitis (FREoE) in Children and Teens!

My background is that I was trained in general pediatrics and pediatric gastroenterology at the Children’s Hospital of Philadelphia. I am currently in sunny Orlando, Florida at Nemours Children’s Hospital and serve as the Division Chief for the Division of Gastroenterology, Hepatology and Nutrition. I have had the privilege to care for patients with EoE for over 12 years. 

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.

James P. Franciosi Signature

James P. Franciosi M.D., M.S., M.S.C.E., F.A.A.P.
Chief, Division of Gastroenterology, Hepatology and Nutrition

Help us to pioneer better treatments and research for EoE.

If you are interested in participating in our trial, call us or click the link below to email our study team.

Contact Us

Resources

Questions? We are here to help!

Click the link below for additional resources or email us at eoeorlando@nemours.org