Confocal Endomicroscopy for Non-Erosive Reflux Disease Detection
NCT ID: NCT02788591
Last Updated: 2022-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
5 participants
INTERVENTIONAL
2015-08-31
2021-06-30
Brief Summary
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Evaluate response to NERD treatment between patients with normal endomicroscopy findings compared with patients with abnormal endomicroscopy findings.
Secondary Objectives:
To evaluate the role of probe based endomicroscopy in the diagnosis of NERD by evaluating dilated intercellular spaces, evaluation of IPCL, and quantification of fluorescein leak.
Quality of life at study entry and end of study. Compare two medications under study within each group as a subgroup analysis.
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Detailed Description
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The confocal endomicroscopy procedure utilizes a powerful microscope that is used during an endoscopy. An endoscopy is a procedure that allows us to scope/view the inside of the esophagus and stomach using a camera in precise detail.
An endoscopy procedure and measurements of acid in the esophagus have been used to determine if the investigators think acid is causing the symptoms. Traditionally, acid blocking medications called proton pump inhibitors (PPIs such as Esomeprazole, Lansoprazole, Omeprazole, and Pantoprazole), or medications such as Sucralfate have been used to treat the symptoms of NERD.
The medical community believes that these symptoms are due to increased spaces between the cells that make up the esophagus. They can directly see those spaces using the confocal endomicroscopy.
Patients are asked to participate in this study if they are 18 years of age or older and have typical symptoms for patients diagnosed with NERD that have not responded to the first attempted medication.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
DIAGNOSTIC
NONE
Study Groups
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Proton Pump Inhibitor (PPI) Therapy
2x daily Proton Pump Inhibitor (PPI) Therapy for 8 weeks
Proton Pump Inhibitor (PPI) Therapy
Subject will take a proton pump inhibitor (PPI) of their choice (Omeprazole, Esomeprazole, Pantoprazole, or Lansoprazole) 2 times a day for 8 weeks.
Sucralfate
4x daily Sucralfate slurry, 1g, for 8 weeks
Sucralfate
Subject will take Sucralfate 4 times a day for 8 weeks.
Interventions
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Proton Pump Inhibitor (PPI) Therapy
Subject will take a proton pump inhibitor (PPI) of their choice (Omeprazole, Esomeprazole, Pantoprazole, or Lansoprazole) 2 times a day for 8 weeks.
Sucralfate
Subject will take Sucralfate 4 times a day for 8 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subjects without gastroesophageal reflux disease (GERD) undergoing upper endomicroscopy for other indications will be recruited into study as controls.
Exclusion Criteria
2. Use of twice daily proton pump inhibitor within 4 weeks of study entry
3. Esophageal varices
4. Coagulopathy (aspirin, NSAIDS and Plavix are allowed. Coumadin, Xarelto, heparin are not allowed.)
5. Gastrointestinal cancer or mass
6. Previous surgery involving the esophagus, stomach or duodenum
7. Pregnancy
8. Allergy to either sucralfate or proton pump inhibitors
18 Years
ALL
Yes
Sponsors
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LCMC Health
OTHER
Responsible Party
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Virendra Joshi
Physician, Gastroenterology
Principal Investigators
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Virendra Joshi, MD
Role: PRINCIPAL_INVESTIGATOR
LCMC Health
Locations
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Touro Infirmary New Orleans
New Orleans, Louisiana, United States
University Medical Center New Orleans
New Orleans, Louisiana, United States
Countries
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Other Identifiers
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CENERDD
Identifier Type: -
Identifier Source: org_study_id
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