Why are we doing this research?
Cincinnati Children’s is conducting a research study, sometimes known as a clinical trial or clinical study, to test and compare the effects (good and bad) of 2 elimination dietary therapies in people diagnosed with Eosinophilic Esophagitis, or EoE.
The 2 therapies are the 1 food (milk) elimination diet, or 1FED, versus the 6 food (milk, egg, wheat, soy, peanut/tree nuts, and fish/shellfish) elimination diet, or 6FED.
We will also try to find out how people with EoE do when using swallowed glucocorticoids (Flovent). A glucocorticoid is a steroid-like medicine that works to decrease inflammation.
What will happen in the study?
If you qualify and you decide to participate in this research study, you will have between 6 to 10 study visits. We will ask you to visit Cincinnati Children’s for some of the visits and for others study staff will call you.
This study consists of 2 phases, Phase 1 and Phase 2. Screening can last up to 4 weeks, and phases 1 and 2 are each 6 weeks long. You will be in the research study for at least 10 weeks and no more than 16 weeks. Only those participants whose EoE does not improve with the elimination diet therapy in Phase 1 will continue to Phase 2 of this study.
The following is a list of some of the tests and procedures that may happen during the study:
- Review of demographic information
- Review of your medical history (including your diet and overall health)
- Review of your family’s medical history
- Physical exam (including height, weight, blood pressure, heart rate, breathing rate and temperature)
- Collection of blood sample(s)
- Collection of up to 4 extra esophageal biopsies: A small piece of tissue from your esophagus is taken during the endoscopy to measure your body’s response to diet and/or swallowed Flovent therapy.
- Study questionnaires: The questionnaires will ask you about your quality of life, symptoms, and dietary intake.
- Collection of urine sample for pregnancy test (for females only)
- Prick skin testing for allergies: Small pricks are made on the skin where a drop of allergen is then placed via a solution. The area may become red, raised, and itchy.
- Patch skin testing: A solution with the allergen is placed on a pad and taped to the skin for 24 to 72 hours. If a red, raised itchy area develops, the person is probably allergic to the allergen that is being tested.
During Phase 1, you will be randomly assigned (like flipping a coin) to 1 of the 2 diets (1FED or 6FED). You will be on the diet for 6 weeks. The choice of which diet you will be asked to follow is random, meaning that there is an equal chance of being in either group. You cannot choose which diet group you want to be in for the study.
If your EoE is no longer active after being on 1 of the diets, your time in the study will be complete.
If your EoE does not improve and you were on the 1FED diet in Phase 1, you will start the 6FED.
If you were on the 6FED in Phase 1, you will start using Flovent (the medicine that you spray into your mouth and swallow) 2 times a day. You will stay on this diet or medication for 6 weeks. After 6 weeks, you are finished with the study, whether you were on diet therapy or the FLovent.
Your Diet and Other Medications
Throughout the study, you should not eat foods that are not part of the diet you have been assigned (1FED or 6FED) or take any medication that is not allowed, if possible. To help you understand your diet, a Registered Dietitian will provide instructions. If there are changes to your diet or medication at any time, you should contact a research staff member.
You will have 2 to 3 endoscopies (EGDs) during your time in the study. This is to test how your EoE is doing. EGDs are considered standard of care for individuals with EoE. The EGDs are not study procedures. We ask your permission that your doctor take 4 extra biopsies during the EGDs. We will review the results of the biopsy slides from your EGDs to see if you are getting better.
The study clinician may want to follow up on something from one of your study visits. If this happens, the study team may ask you to come in for extra study visits.
Participants interested in being part of this research will be given a consent form that thoroughly explains all of the details of the study. A member of the study staff will review the consent form with you and will be sure that all of your questions are answered.
What are the good things that can happen from this research?
You may not receive any direct medical benefits from participating in this research study. Other studies of swallowed fluticasone have shown some benefit for people with EoE. The 1FED and 6FED elimination diet therapies have not been formally proven in EoE.
We hope the information learned from this research study may benefit other patients with EoE in the future.
What are the bad things that can happen from this research?
You may experience some risks during this study. Risks may include oozing at the site of the tissue sample; development of a yeast infection (oral thrush) in the mouth or esophagus; and pain, itching, and/or bruising at the location of the blood sample or skin testing for allergies. There may be other risks as well.
A detailed list of possible side effects will be provided to those participants interested in knowing more about this study.
A trained professional will manage the treatment for your EoE during the research study.