7805: Eosinophilic Esophagitis (EoE) Intervention Trial-Randomized 1 Food Elimination vs. 4 Food Elimination Diet followed by Swallowed Glucocorticoids

Status: RECRUITING

 

Study Summary:

The purpose of this interventional study is to test and compare the effectiveness of two elimination diets—the 1-food elimination diet (1FED; removing only milk from the diet) and the 4-food elimination diet (4FED; removing milk, egg, wheat, and soy from the diet). The study will also test the effectiveness of swallowed glucocorticoid therapy in some of the study participants for whom diet therapy was not effective.

 

For Diseases:

  • Eosinophilic Esophagitis (EoE)
 

Background:

People with a diagnosis of eosinophilic esophagitis (EoE) experience various symptoms in addition to microscopic damage to their digestive tract. There is no known cure for EoE, although effective treatments exist.

This study aims:

  1. This study aims to test dietary therapies for EoE to see how effective they are and to monitor participants’ symptoms and quality of life while participating in the study.
  2. This study aims to identify the best dietary approach, with a focus on removing as few foods as possible from the diet.
  3. This study aims to understand how to predict responsiveness to dietary therapies.

 

About this Study:

This is an interventional study of 292 individuals with EoE between the ages of 6-17 years of age. The study plans to enroll 50 participants between the ages of 6 and 7, approximately 120 participants between the ages of 8 and 12 years, and approximately 120 participants between the ages of 13 and 17 years of age. Participants will be seen at EoE clinical sites around the United States. Participants will be randomly assigned to one of the two elimination diet therapies, the 1FED or the 4FED. If a participant’s EoE is in remission after receiving 12 weeks of 1FED or 6FED therapy, the participant will be done with study participation. If a participant’s EoE is still active, the participant will continue on to either 4FED therapy (if they were previously on 1FED) or swallowed glucocorticoid therapy (if they were previously on 4FED) for 12 weeks. Study benefits can be found here.

During the study, you will be asked to:

  • Keep a log of what you eat for three days, complete dietary questionnaires, and talk to a dietitian about what you eat
  • Have a physical exam
  • Have vital signs (heart rate, blood pressure, temperature, breathing rate) measured
  • Fill out feedback forms about your symptoms and quality of life
  • Give blood (1 to 2 teaspoons at a time)
  • Have a pregnancy test (female participants only)
  • Have skin prick and skin patch allergy testing
  • Follow/take the assigned study therapy (1FED, 4FED, or swallowed glucocorticoids)

As part of standard of care (your normal care) you will:

  • Have an endoscopy
  • Have a biopsy (As part of standard of care endoscopy, the doctor will take small sections of your esophagus tissue (biopsies) to check cells.)
 

Who Can Join:

To be eligible to participate, you must:

  • Be male or female age 6 to 17
  • Be diagnosed with:
    • Eosinophilic Esophagitis (EoE)
  • Have symptoms of EoE
  • Have esophageal eosinophilia (eosinophils in your esophagus)
  • Be female, and not pregnant or plan to become pregnant during the study

You are not eligible to participate if:

  • You have been treated with topical swallowed steroids within the last 2 months or systemic steroids within the last 3 months
  • You have eosinophils in other parts of your GI tract (for example, the stomach or colon)
  • You have been diagnosed with a GI malabsorption disorder (Inflammatory Bowel Disease, Crohn’s Disease) or Celiac Disease
  • You are currently on dietary therapy strictly avoiding milk or on a 4FED
  • You currently have H pylori gastritis or a parasitic infection
  • You have a history of anaphylaxis (a severe allergic reaction) to milk
  • You have used investigational drugs (i.e. participated in a drug study) within 4 weeks prior to starting the study
  • You are receiving any medications that are not allowed while on the study
  • You are on immunotherapy for pollen (if not on maintenance therapy) or IgE-mediated food allergy
  • You have other medical conditions or findings that the doctor feels make participation in the study unsafe
 

How to Join:

In order to participate in a study, you must personally contact the study coordinator of any of the participating institutions by phone or by e-mail. Please use the information below to inquire about participation.

Arkansas

Arkansas Children's Hospital, Little Rock
Contact: Robin Gibson, RN, Clinical Research Coordinator
Phone: 501-364-1542
Email: GibsonRobinA@uams.edu

California

Rady Children's Hospital, San Diego
Contact: Seema Aceves, MD, PhD, Principal Investigator
Phone: 858-966-5961
Email: Saceves@ucsd.edu

Colorado

Children's Hospital Colorado, Denver
Contact: Leslie Young, Clinical Research Coordinator 
Phone: 720-777-5739
Email: Leslie.Young@childrenscolorado.org

Illinois

Ann & Robert H. Lurie Children's Hospital, Chicago
Contact: Jessica Ross, Clinical Research Coordinator 
Phone: 312-227-4582
Email: JNRoss@luriechildrens.org

Massachusetts

Tufts Medical Center, Boston
Contact: Pedro Eman, MD, Clinical Research Coordinator 
Phone: 617-636-4941
Email: PEman@tuftsmedicalcenter.org

New York

Mt. Sinai Hospital, New York City
Contact: Mirna Chehade,MD, Principal Investigator
Phone: 212-659-1414
Email: Mirna.Chehade@mssm.edu

North Carolina

University of North Carolina, Chapel Hill
Contact: Deanna Hamilton, RN, Clinical Research Coordinator 
Phone: 919-962-4405
Email: DHamilto@email.unc.edu

Ohio

Cincinnati Children's Hospital Medical Center (CCHMC), Cincinnati
Contact: Kara Kliewer, PhD, RD, Clinical Research Coordinator 
Phone: 513-636-4821
Email: Kara.Kliewer@cchmc.org

Pennsylvania

Children's Hospital of Philadelphia, Philadelphia
Contact: Deirdre Burke, Clinical Research Coordinator 
Phone: 267-426-8603
Email: BurkeD2@email.chop.edu

 
 

Learn about all the benefits of joining the RDCRN Contact Registry.

Join Now
 

Prinicipal Investigator:

Marc E. Rothenberg M.D., Ph.D.