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

NCT02039869 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2015-12-09

No results posted yet for this study

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.

Conditions

  • Gastroesophageal Reflux Disease
  • Non Erosive Reflux Disease
  • Dyspepsia

Interventions

DEVICE

Confocal endomicroscopy

The probe allows microscopic evaluation of tissue in real time during endoscopy.

DRUG

Proton pump inhibitor

Acid suppressing medication (over the counter)

DRUG

Sucralfate

Coating agent for damaged intestinal lining.

Sponsors & Collaborators

  • Medical University of South Carolina

    collaborator OTHER

  • Ochsner Health System

    collaborator OTHER

  • Virginia Commonwealth University

    lead OTHER

Principal Investigators

  • George B Smallfield, MD, MSPH · Virginia Commonwealth University

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Primary Completion
2015-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02039869 on ClinicalTrials.gov