A Study Using the Esophageal Sponge to Gather Specimens for Management of Dietary Therapy in Eosinophilic Esophagitis
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 15-004741
NCT ID: NCT02599558
Sponsor Protocol Number: 15-004741
About this study
The purpose of this study is to see if the cytosponge ( a 10 minute, in office procedure that does not require sedation) can be used to replace the 6-10 endoscopies that are routinely performed during the standard of care dietary restriction and food reintroduction trials to manage eosinophilic esophagitis.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
- 18 to 80 years of age.
- Diagnosed with Eosinophilic Esophagitis > than 15 Eos phf.
- Going through the six food elimination diet or have just completed elimination of the six foods: fish, nuts, eggs, soy, wheat, and milk.
- Patients that have completed the six food elimination diet clinically and none of the foods were identified as being the food causing their EoE.
Exclusion Criteria
- Clinical evidence of infectious process potentially contributing to dysphagia ( candidiasis, CMV, herpes).
- Other cause of dysphagia identified at endoscopy (e.g. reflux esophagitis, stricture, web, ring, achalasia, esophageal neoplasm).
- Esophageal minimal diameter < 13 mm on structured barium esophagram.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Jeffrey Alexander, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available