Status: Closed

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; milk only) and the 6-food elimination diet (6FED; milk, egg, wheat, soy, tree nut/peanuts, and fish/shellfish).  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 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. The study will also test the effectiveness of swallowed glucocorticoid therapy in some of the participants for whom dietary therapy was not effective. We aim to identify the best dietary approach, with a focus on minimal food eliminations, and to understand how to predict responsiveness.

About this Study

This is an interventional study of 120 individuals with EoE between the ages of 18 and 60 years of age. Participants will be seen at one of the clinical sites around the United States. Participants will be in the study for approximately 10 weeks to 17 weeks, depending on how they respond to the dietary therapy. Participants will be randomly assigned to one of the two elimination diet therapies, the 1FED or the 6FED. If a participant’s EoE is in remission after receiving 6 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 6FED therapy (if they were previously on 1FED) or swallowed glucocorticoid therapy (if they were previously on 6FED) for 6 weeks.

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, 6FED, 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.)

Targeted Enrollment

To be eligible to participate, you must:

• Be male or female age 18-60
• Be diagnosed with:Eosinophilic esophagitis (EoE)
• Have symptoms of EoE
• Have esophageal eosinophilia (eosinophils in your esophagus)

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 6FED
• 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

Visit clinicaltrials.gov to view the study results.