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

Primary Purpose

Non-erosive Reflux Disease, Gastroesophageal Reflux

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Proton Pump Inhibitor (PPI) Therapy
Sucralfate
Sponsored by
LCMC Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Non-erosive Reflux Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Touro Infirmary New Orleans
  • University Medical Center New Orleans

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Proton Pump Inhibitor (PPI) Therapy

Sucralfate

Arm Description

2x daily Proton Pump Inhibitor (PPI) Therapy for 8 weeks

4x daily Sucralfate slurry, 1g, for 8 weeks

Outcomes

Primary Outcome Measures

Evaluate non erosive reflux disease (NERD) Symptoms.
Reflux Disease Questionnaire (RDQ)

Secondary Outcome Measures

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.
Compare quality of life in patients with NERD.
Quality of life questionnaire (SF-36)
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.

Full Information

First Posted
March 17, 2016
Last Updated
January 25, 2022
Sponsor
LCMC Health
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1. Study Identification

Unique Protocol Identification Number
NCT02788591
Brief Title
Confocal Endomicroscopy for Non-Erosive Reflux Disease Detection
Acronym
CENERDD
Official Title
Confocal Endomicroscopy for Non-Erosive Reflux Disease Detection (CENERDD)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Terminated
Why Stopped
lack of accrual
Study Start Date
August 2015 (Actual)
Primary Completion Date
June 2021 (Actual)
Study Completion Date
June 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
LCMC Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-erosive Reflux Disease, Gastroesophageal Reflux

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Proton Pump Inhibitor (PPI) Therapy
Arm Type
Other
Arm Description
2x daily Proton Pump Inhibitor (PPI) Therapy for 8 weeks
Arm Title
Sucralfate
Arm Type
Other
Arm Description
4x daily Sucralfate slurry, 1g, for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Proton Pump Inhibitor (PPI) Therapy
Other Intervention Name(s)
Omeprazole, Esomeprazole, Pantoprazole, Lansoprazole
Intervention Description
Subject will take a proton pump inhibitor (PPI) of their choice (Omeprazole, Esomeprazole, Pantoprazole, or Lansoprazole) 2 times a day for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Sucralfate
Other Intervention Name(s)
Carafate
Intervention Description
Subject will take Sucralfate 4 times a day for 8 weeks.
Primary Outcome Measure Information:
Title
Evaluate non erosive reflux disease (NERD) Symptoms.
Description
Reflux Disease Questionnaire (RDQ)
Time Frame
20 weeks
Secondary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
20 weeks
Title
Compare quality of life in patients with NERD.
Description
Quality of life questionnaire (SF-36)
Time Frame
20 weeks
Title
Compare two medications within each NERD study groups as a subgroup analysis.
Description
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.
Time Frame
20 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Subjects without gastroesophageal reflux disease (GERD) undergoing upper endomicroscopy for other indications will be recruited into study as controls. Exclusion Criteria: Barrett's esophagus Use of twice daily proton pump inhibitor within 4 weeks of study entry Esophageal varices Coagulopathy (aspirin, NSAIDS and Plavix are allowed. Coumadin, Xarelto, heparin are not allowed.) Gastrointestinal cancer or mass Previous surgery involving the esophagus, stomach or duodenum Pregnancy Allergy to either sucralfate or proton pump inhibitors
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Virendra Joshi, MD
Organizational Affiliation
LCMC Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Touro Infirmary New Orleans
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
University Medical Center New Orleans
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Confocal Endomicroscopy for Non-Erosive Reflux Disease Detection

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