Why are we doing this research?
This is a multi-site 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 4 food (milk, egg, wheat and soy) elimination diet, or 4FED.
Researchers also want to see how someone with EoE responds to swallowed glucocorticoids (Flovent), when they did not respond to the 4 food elimination diet. A glucocorticoid is a steroid-like medicine that works to decrease inflammation.
What will happen in the study?
If your child qualifies and you/your child decide to participate, your child will have up to 10 study visits. Study staff will ask you to visit one of the participating institutions for some of the visits and for others staff will call you.
This study consists of 2 phases, Phase I and Phase II, each lasting 3 months. Your child will be in this research study for at least 3 months (Phase 1) and no more than 6 months (Phase I and II).
The following is a list of some of the tests and procedures that may happen during the study:
- Review of your child’s demographic information
- Review of your child’s medical, medication and dietary history
- Physical exam (including height, weight, blood pressure, heart rate, breathing rate and temperature)
- Collection of blood samples
- Collection of up to 4 extra esophageal biopsies (per endoscopy) for research: 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 about your child’s quality of life, symptoms, dietary intake and how he or she is feeling overall (you/your child will complete these 8 times throughout the study).
- Collection of urine sample for pregnancy test (for menstruating 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 possible allergen is placed on a pad and taped to the skin for 24 to 72 hours. If a red, raised and itchy area develops; the person is probably allergic to the allergen that is being tested.
- Diet diary: Your child will be asked to complete diet diaries several times throughout the study.
During Phase I, your child will be randomly assigned (like flipping a coin) to 1 of the 2 diets (1FED or 4FED). The choice of which diet your child will be asked to follow is random, meaning that there is an equal chance of being in either group. Your child cannot choose which diet group he or she wants to be in for the study.
Your child’s participation in the study will end if his or her EoE improves after Phase I.
If your child is on the 1FED therapy in Phase I and his or her EoE does not improve, your child will switch to the 4FED in Phase II of this study.
If your child is on the 4FED therapy in Phase I and his or her EoE does not improve, your child will continue to Flovent in Phase II of this study. Not all participants will receive the study drug, Flovent. Flovent is an inhaler that spays the medication in the mouth, which is then swallowed and coats the esophagus.
Your child will have 2 to 3 endoscopies (EGDs) during his or her time in the study. This is to test how your child’s EoE is doing.
EGDs are considered standard of care for individuals with EoE and are not study procedures. We will ask your permission that your child’s doctor take 4 extra biopsies during the EGDs. We will review the results of the biopsy slides from the EGDs, as well as the slides themselves, to see if your child is getting better.
If your child has had an EGD with biopsies performed at one of the participating institutions, or another institution, within 4 weeks of the scheduled screening visit, he or she does not have to repeat the EGD. A research pathologist will review the slides as well as the results of your child’s most recent EGD. These will be used in part to determine your child’s study eligibility.
Diet and Other Medications
Throughout the study, if possible, your child should not eat foods that are not part of the diet he or she been assigned (1FED or 4FED) or take any medications that are not allowed. To help your child understand his or her diet, a Registered Dietitian will provide instructions. If there are changes to your child’s diet or medications at any time, you should contact a research staff member.
The study clinician may want to follow up on something from one of your child’s study visits. If this happens, the study team may ask your child to come in for extra visits.
Participants, parents and/or legal guardians 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?
Your child 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 effectiveness of the 1FED and 4FED elimination diet therapies has 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?
Your child 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, parents and/or legal guardians interested in knowing more about this study.
A trained professional will manage the treatment for your child’s EoE during the research study.