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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT01865825
Date of registration: 23/05/2013
Prospective Registration: No
Primary sponsor: Mayo Clinic
Public title: Proton Pump Inhibitor (PPI) Responsive Eosinophilic Esophagitis EoE: Gastroesophageal Reflux Disease (GERD) or Eosinophilic Esophagitis (EoE)?
Scientific title: PPI Responsive Esophageal Eosinophilia: GERD or Eosinophilic Esophagitis?
Date of first enrolment: March 2013
Target sample size: 20
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT01865825
Study type:  Observational
Study design:   
Phase:  N/A
Countries of recruitment
United States
Contacts
Name:     Jeffrey Alexander, MD
Address: 
Telephone:
Email:
Affiliation:  Mayo Clinic
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Erosive Esophagitis
Intervention(s)
Radiation: Esophageal Barium Xray
Primary Outcome(s)
Abnormal esophageal distensibility in patients with PPI responsive Eosinophilic Infiltrates to patients with Eosionophilic esophagitis and Gastroesophageal Reflux Disease. [Time Frame: 1 year]
Secondary Outcome(s)
The relationship of abnormal esophageal distensibility to other endoscopic findings of EoE (furrows, rings, fragility, stricture) [Time Frame: 1 year]
Secondary ID(s)
12-009305
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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