NCT02788591

Confocal Endomicroscopy for Non-Erosive Reflux Disease Detection

Confocal Endomicroscopy for Non-Erosive Reflux Disease Detection (CENERDD)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: LCMC Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Primary Objective: 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.

Detailed description

The purpose of this study is to evaluate response to non-erosive reflux disease (NERD) treatment between patients with normal endomicroscopy findings compared with patients with abnormal endomicroscopy findings. The researchers will compare two different drug regimens for the NERD subjects to evaluate their effectiveness in reducing NERD-related symptoms. In addition, the researchers will be testing the function and effectiveness of the confocal endomicroscopy procedure to be used during the study. Researchers will be continuing to assess the status, symptoms, and any changes associated with the symptoms subjects are experiencing. 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

• Non-erosive Reflux Disease
• Gastroesophageal Reflux

Interventions

Type	Name	Description
DRUG	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.
DRUG	Sucralfate	Subject will take Sucralfate 4 times a day for 8 weeks.

Timeline

• Start date: 2015-08-01
• Primary completion: 2021-06-01
• Completion: 2021-06-01
• First posted: 2016-06-02
• Last updated: 2022-02-09

Locations

2 sites across 1 country: United States