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Confocal Endomicroscopy for Non-Erosive Reflux Disease Detection

NCT02788591 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2022-02-09

No results posted yet for this study

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.

Conditions

  • Non-erosive Reflux Disease
  • Gastroesophageal Reflux

Interventions

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.

DRUG

Sucralfate

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

Sponsors & Collaborators

  • LCMC Health

    lead OTHER

Principal Investigators

  • Virendra Joshi, MD · LCMC Health

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2021-06-30
Completion
2021-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02788591 on ClinicalTrials.gov