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

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

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.

Study Overview

• Status: Terminated
• Conditions: Gastroesophageal Reflux; Non-erosive Reflux Disease
• Intervention / Treatment: Drug: Proton Pump Inhibitor (PPI) Therapy; Drug: Sucralfate

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.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • University Medical Center New Orleans
    • New Orleans, Louisiana, United States, 70112
      • Touro Infirmary New Orleans

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Individuals older than 18 years who score a 12 or greater on the Reflux Disease Questionnaire and have failed a four week trial of daily proton pump inhibitor.
2. Subjects without gastroesophageal reflux disease (GERD) undergoing upper endomicroscopy for other indications will be recruited into study as controls.

Exclusion Criteria:

1. Barrett's esophagus
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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Proton Pump Inhibitor (PPI) Therapy; 2x daily Proton Pump Inhibitor (PPI) Therapy for 8 weeks	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.; Other Names: Omeprazole, Esomeprazole, Pantoprazole, Lansoprazole
Other: Sucralfate; 4x daily Sucralfate slurry, 1g, for 8 weeks	Drug: Sucralfate; Subject will take Sucralfate 4 times a day for 8 weeks.; Other Names: Carafate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate non erosive reflux disease (NERD) Symptoms.	Reflux Disease Questionnaire (RDQ)	20 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	A 3 minute video recording of microscopic images starting with the injection of the fluorescein will be captured during the time of endoscopy. The goal is also to see if the time to seeing fluorescein in the intracellular spaces correlates with a diagnosis of NERD. Time, measured in seconds, to first visualization of intrapapillary loops and intercellular gaps and fluorescein leak will be obtained and assess by trained endoscopists.	20 weeks
Compare quality of life in patients with NERD.	Quality of life questionnaire (SF-36)	20 weeks
Compare two medications within each NERD study groups as a subgroup analysis.	Categorical and binary demographics and outcomes will be assessed through a likelihood-ratio chi square test or a Fischer's exact test.Continuous outcomes, including time to fluorescein intracellular, will be assessed through a Student's t test or Wilcoxon rank sum, if the distribution of particular continuous variables is non-normal, tested through a Shapiro-Wilk statistic. Statistical significance will be determined at p values less than 0.05.	20 weeks

Collaborators and Investigators

• Sponsor: LCMC Health
• Investigators: Principal Investigator: Virendra Joshi, MD, LCMC Health

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2015
• Primary Completion (Actual): June 1, 2021
• Study Completion (Actual): June 1, 2021

Study Registration Dates

• First Submitted: March 17, 2016
• First Submitted That Met QC Criteria: May 26, 2016
• First Posted (Estimate): June 2, 2016

Study Record Updates

• Last Update Posted (Actual): February 9, 2022
• Last Update Submitted That Met QC Criteria: January 25, 2022
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastroesophageal Reflux; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Lansoprazole; Omeprazole; Sucralfate; Esomeprazole; Pantoprazole; Proton Pump Inhibitors
• Other Study ID Numbers: CENERDD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No