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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Erosive Esophagitis Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Esophageal Barium Xray

Radiation

•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 outcomes

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 outcomes

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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

PPI Responsive Esophageal Eosinophilia: GERD or Eosinophilic Esophagitis?

Important dates

Study start: 2013
Primary completion: 2016
Study completion: 2017
First posted: May 31, 2013
Registry last updated: Mar 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed