Clinical trial NCT02788591: Confocal Endomicroscopy for Non-Erosive Reflux Disease Detection
Official title: Confocal Endomicroscopy for Non-Erosive Reflux Disease Detection (CENERDD)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Non-erosive Reflux Disease
Gastroesophageal Reflux
Lead sponsor: LCMC Health
Sponsor class: OTHER
First posted: 2016-06-02
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Evaluate non erosive reflux disease (NERD) Symptoms.
timeFrame: 20 weeks
Secondary outcomes:
measure: 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.
timeFrame: 20 weeks
measure: Compare quality of life in patients with NERD.
timeFrame: 20 weeks
measure: Compare two medications within each NERD study groups as a subgroup analysis.
timeFrame: 20 weeks
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Touro Infirmary New Orleans
state: Louisiana
city: New Orleans
country: United States
facility: University Medical Center New Orleans
state: Louisiana
Study officials:
affiliation: LCMC Health
name: Virendra Joshi, MD
role: PRINCIPAL_INVESTIGATOR
References: