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

LCMC Health

Status: Terminated

Conditions: Non-erosive Reflux Disease; Gastroesophageal Reflux

Treatments: Drug: Proton Pump Inhibitor (PPI) Therapy; Drug: Sucralfate

Study type: Interventional

Funder types: Other

Identifiers

NCT02788591

CENERDD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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5 participants in 2 patient groups

Proton Pump Inhibitor (PPI) Therapy

Other group

Description:

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

Treatment:

Drug: Proton Pump Inhibitor (PPI) Therapy

Sucralfate

Other group

Description:

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

Treatment:

Drug: Sucralfate