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

PPI Responsive Esophageal Eosinophilia: GERD or Eosinophilic Esophagitis?

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01865825
Enrollment
20
Registered
2013-05-31
Start date
2013-03-31
Completion date
2017-03-31
Last updated
2017-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erosive Esophagitis

Keywords

Erosive Esophagitis, Gastroesophageal reflux disease

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.

Interventions

RADIATIONEsophageal 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.

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Abnormal esophageal distensibility in patients with PPI responsive Eosinophilic Infiltrates to patients with Eosionophilic esophagitis and Gastroesophageal Reflux Disease.1 yearWe 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

MeasureTime frameDescription
The relationship of abnormal esophageal distensibility to other endoscopic findings of EoE (furrows, rings, fragility, stricture)1 yearAfter 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026