Confocal Endomicroscopy for Non-Erosive Reflux Disease Detection

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

Sponsors

Lead Sponsor: LCMC Health

Source LCMC Health
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.

Overall Status Recruiting
Start Date 2015-08-01
Completion Date 2021-06-01
Primary Completion Date 2020-12-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Evaluate non erosive reflux disease (NERD) Symptoms. 20 weeks
Secondary Outcome
Measure 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. 20 weeks
Compare quality of life in patients with NERD. 20 weeks
Compare two medications within each NERD study groups as a subgroup analysis. 20 weeks
Enrollment 140
Condition
Intervention

Intervention Type: Drug

Intervention Name: Proton Pump Inhibitor (PPI) Therapy

Description: Subject will take a proton pump inhibitor (PPI) of their choice (Omeprazole, Esomeprazole, Pantoprazole, or Lansoprazole) 2 times a day for 8 weeks.

Arm Group Label: Proton Pump Inhibitor (PPI) Therapy

Other Name: Omeprazole, Esomeprazole, Pantoprazole, Lansoprazole

Intervention Type: Drug

Intervention Name: Sucralfate

Description: Subject will take Sucralfate 4 times a day for 8 weeks.

Arm Group Label: Sucralfate

Other Name: Carafate

Eligibility

Criteria:

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Virendra Joshi, MD Principal Investigator LCMC Health
Overall Contact

Last Name: Virendra Joshi, MD

Phone: 504-702-3000

Email: [email protected]

Location
Facility: Status: Contact:
Touro Infirmary New Orleans | New Orleans, Louisiana, 70112, United States Recruiting Jeannine Ascani 504-702-3141 [email protected]
University Medical Center New Orleans | New Orleans, Louisiana, 70112, United States Recruiting Jeannine Ascani 504-702-3141 [email protected]
Location Countries

United States

Verification Date

2020-09-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: LCMC Health

Investigator Full Name: Virendra Joshi

Investigator Title: Physician, Gastroenterology

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Proton Pump Inhibitor (PPI) Therapy

Type: Other

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

Label: Sucralfate

Type: Other

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

Acronym CENERDD
Patient Data Undecided
Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Diagnostic

Masking: None (Open Label)

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