Overview

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

Status:
Withdrawn

Trial end date:
1969-12-31

Target enrollment:
0

Participant gender:
All

Summary

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.

Phase:

N/A

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Virginia Commonwealth University

Collaborators:

Medical University of South Carolina
Ochsner Health System

Treatments:

Omeprazole
Proton Pump Inhibitors
Sucralfate

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. Barrett's esophagus

2. Use of high dose proton pump inhibitor within 4 weeks of study entry

3. Esophageal varices

4. Coagulopathy

5. GI cancer or mass

6. Previous surgery involving the esophagus, stomach or duodenum

7. Pregnancy

8. Allergy to either sucralfate or proton pump inhibitors