Confocal Endomicroscopy for Non-Erosive Reflux Disease (CE NERD)

Withdrawn before enrolling · Not applicable

Conditions studied: Gastroesophageal Reflux Disease, Non Erosive Reflux Disease, Dyspepsia

In brief

The purpose of this study is to find out if people who have non-erosive reflux disease (NERD) have changes the investigators can see with a microscope (called confocal endomicroscopy) that is used during endoscopy (a camera scope evaluation of the inside of your stomach and swallowing tube). Traditionally the investigators have used trials of acid blocking medications (PPIs), endoscopy and measurements of acid in the swallowing tube (the esophagus) to determine if the investigators think acid is causing troublesome symptoms. The medical community believes that these symptoms are due to increased spaces between the cells that make up the swallowing tube. The investigators can directly see those spaces with a new microscope that the investigators can pass through the camera scope. Participants will be assigned to take one of two medications omeprazole and sucralfate (both approved medications for stomach symptoms) to treat their symptoms and record how well the treatment works. The investigators then will look to see if the microscope can predict which medication will work best for patients in the future. The investigators also plan to measure the acid levels in your swallowing tube and do a camera evaluation of your swallowing tube and stomach as this is standard for patients with your symptoms. The investigators will compare the results of those studies to the microscope findings.

Key facts

Study ID

NCT02039869

Run by

Virginia Commonwealth University

People needed

0

Last updated by the study team

2015-12-09

Who can join

Age: 18 and older, up to 79. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Individuals with reflux disease between the ages of 18 and 79 who have failed a trial of daily PPI.

You may not qualify if…

• Barrett's esophagus
• Use of high dose proton pump inhibitor within 4 weeks of study entry
• Esophageal varices
• Coagulopathy
• GI cancer or mass
• Previous surgery involving the esophagus, stomach or duodenum
• Pregnancy
• Allergy to either sucralfate or proton pump inhibitors

Where it is running

• Ochsner Medical Center — Kenner, Louisiana, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Virginia Commonwealth University — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.