Proton Pump Inhibitor (PPI) Responsive Eosinophilic Esophagitis EoE: Gastroesophageal Reflux Disease (GERD) or Eosinophilic Esophagitis (EoE)?

Overview

The investigators would like to determine if there are patients with PPI responsive Eosinophilic Esophagitis Infiltration that have significant loss of esophageal distensibility suggestive of esophageal fibrosis typical of classic Eosniophilic Esophagitis. If this group of patients exists, the investigators would like to determine if they have the typical endoscopic features of EoE rather than those of GERD.

Full Title of Study: “PPI Responsive Esophageal Eosinophilia: GERD or Eosinophilic Esophagitis?”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 2016

Interventions

  • Radiation: Esophageal Barium Xray
    • •Fast for 4 hours prior to the Esophagram (upper GI x-ray). You will drink a liquid that has barium or another contrast agent in it. The radiologist will use the X-ray machine to look at your upper GI tract while you drink the contrast liquid. The x-ray exam should take between 10-15 minutes. We will have patients complete the Mayo Dysphasia Questionnaire-30 day.

Arms, Groups and Cohorts

  • Esophageal barium xray
    • We will recruit 20 patients with GERD without dysphagia for an esophageal barium xray for esophageal diameter measurements. The 20 Gastroesophageal Reflux Disease (GERD) patients will complete the Mayo Dysphagia Questionnaire 30-day and the Eosinophilic Esophagitis Actitivy Index (EEsAI) questionnaires

Clinical Trial Outcome Measures

Primary Measures

  • Abnormal esophageal distensibility in patients with PPI responsive Eosinophilic Infiltrates to patients with Eosionophilic esophagitis and Gastroesophageal Reflux Disease.
    • Time Frame: 1 year
    • We will evaluate endoscopic features of Gastroesophageal Reflux Disease(GERD) by reviewing endoscopic reports and images. The presence of esophageal narrowing, furrows, rings, fragility, and white spots will be noted form the endoscopic reports prior to the initiation of the Provation report system. We will review the endoscopic reports and the endoscopic photographs on those patients evaluated after the Provation report system was initiated. All images will be reviewed by one investigator unaware of the subjects clinical data and name

Secondary Measures

  • The relationship of abnormal esophageal distensibility to other endoscopic findings of EoE (furrows, rings, fragility, stricture)
    • Time Frame: 1 year
    • After reviewing endoscopic features of GERD by reviewing endoscopic reports and images. The presence of esophageal narrowing, furrows, rings, fragility, and white spots will be noted form the endoscopic reports prior to the initiation of the Provation report system. We will determine the relationship of abnormal esophagus distensibility to the endoscopic findings

Participating in This Clinical Trial

Inclusion Criteria

  • Age 18 or older – Have either mild-to-moderate Los Angeles (LA) Classification System grade B, moderately severe LA grade C, or severe LA grade D erosive reflux esophagitis – Or patients having a clinically indicated pH/impedance monitoring on proton pump inhibitor therapy for indications of gastroesophageal reflux disease. Exclusion criteria:

  • Neoplasm of the esophagus or stomach – Inability to read due to: Blindness, cognitive dysfunction, or English language illiteracy – Disorders which predispose to unreliable responses such as Schizophrenia, Alzheimer's disease or significant memory loss

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Mayo Clinic
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jeffrey A Alexander, Principal Investigator – Mayo Clinic
  • Overall Official(s)
    • Jeffrey Alexander, MD, Principal Investigator, Mayo Clinic

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