Study Stopped
Could not recruit patients - modifying protocol and plan resubmission to our IRB
Confocal Endomicroscopy for Non-Erosive Reflux Disease (CE NERD)
CE_NERD
1 other identifier
interventional
N/A
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 20, 2013
CompletedFirst Posted
Study publicly available on registry
January 20, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedDecember 9, 2015
December 1, 2015
December 20, 2013
December 7, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Response to NERD treatment
We will use a validated measure of reflux disease - the reflux disease questionnaire (RDQ). This questionnaire consists of 12 items assessing various aspects of reflux disease. A score of more than 12 will be required for study entry. Response to treatment will be assessed based on reduction in scores on this survey.
8 weeks
Secondary Outcomes (2)
Confocal endomicroscopy findings
Immediate
Quality of life
8 weeks
Study Arms (2)
Proton Pump Inhibitor
EXPERIMENTALPatients will receive proton pump inhibitor therapy with omeprazole twice daily while we observe for improvement in reflux symptoms. We will compare the confocal endomicroscopy images in the responders to non-responders at the end of 8 weeks to determine if confocal endomicroscopy can select patient that would benefit most from proton pump inhibitor therapy.
Sucralfate
EXPERIMENTALPatients will receive sucralfate therapy four times a day while we observe for improvement in reflux symptoms. We will compare the confocal endomicroscopy images in the responders to non-responders at the end of 8 weeks to determine if confocal endomicroscopy can select patient that would benefit most from sucralfate therapy.
Interventions
The probe allows microscopic evaluation of tissue in real time during endoscopy.
Acid suppressing medication (over the counter)
Coating agent for damaged intestinal lining.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Virginia Commonwealth Universitylead
- Medical University of South Carolinacollaborator
- Ochsner Health Systemcollaborator
Study Sites (3)
Ochsner Medical Center
Kenner, Louisiana, 70065, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
Related Publications (2)
Chu CL, Zhen YB, Lv GP, Li CQ, Li Z, Qi QQ, Gu XM, Yu T, Zhang TG, Zhou CJ, Rui-Ji, Li YQ. Microalterations of esophagus in patients with non-erosive reflux disease: in-vivo diagnosis by confocal laser endomicroscopy and its relationship with gastroesophageal reflux. Am J Gastroenterol. 2012 Jun;107(6):864-74. doi: 10.1038/ajg.2012.44. Epub 2012 Mar 13.
PMID: 22415199BACKGROUNDLaw JD. Clinical and technical results from spinal stimulation for chronic pain of diverse pathophysiologies. Stereotact Funct Neurosurg. 1992;59(1-4):21-4. doi: 10.1159/000098912.
PMID: 1295042BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
George B Smallfield, MD, MSPH
Virginia Commonwealth University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 20, 2013
First Posted
January 20, 2014
Primary Completion
December 1, 2015
Last Updated
December 9, 2015
Record last verified: 2015-12