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

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ClinicalTrials.gov Identifier: NCT01865825
Recruitment Status : Completed
First Posted : May 31, 2013
Last Update Posted : March 22, 2017
Sponsor:
Information provided by (Responsible Party):
Jeffrey A Alexander, Mayo Clinic

Brief Summary:

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.


Condition or disease Intervention/treatment
Erosive Esophagitis Radiation: Esophageal Barium Xray

Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: PPI Responsive Esophageal Eosinophilia: GERD or Eosinophilic Esophagitis?
Actual Study Start Date : March 2013
Actual Primary Completion Date : December 2016
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD X-Rays
Drug Information available for: Barium
U.S. FDA Resources

Group/Cohort Intervention/treatment
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

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.

Other Names:
  • GERD
  • Erosive Esophagitis



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with GERD that have been currently diagnosed with erosive esophagitis at endoscopy, at Mayo Clinic Rochester, Minnesota
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01865825


Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Jeffrey Alexander, MD Mayo Clinic

Responsible Party: Jeffrey A Alexander, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01865825     History of Changes
Other Study ID Numbers: 12-009305
First Posted: May 31, 2013    Key Record Dates
Last Update Posted: March 22, 2017
Last Verified: March 2017

Keywords provided by Jeffrey A Alexander, Mayo Clinic:
Erosive Esophagitis
Gastroesophageal reflux disease

Additional relevant MeSH terms:
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Leukocyte Disorders
Hematologic Diseases
Immune System Diseases
Gastroesophageal Reflux
Esophagitis
Eosinophilic Esophagitis
Gastroenteritis
Eosinophilia
Hypersensitivity, Immediate
Hypersensitivity
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action