A Study Using the Esophageal Sponge to Gather Specimens for Management of Dietary Therapy in Eosinophilic Esophagitis

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes 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.
  • 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. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria

  • Diagnosed with Eosinophilic Esophagitis > than 15 Eos phf and failed to respond to the PPI therapy
  • Going through the six food elimination diet or have just completed elimination of the six foods: fish, nuts, eggs, soy, wheat, and milk

 

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 us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Jeffrey Alexander, M.D.

Open for enrollment

Contact information:

Debra Geno CCRP

(507)538-0367

Geno.Debra@mayo.edu

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CLS-20167663

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