TerminatedNot Applicable

Confocal Endomicroscopy for Non-Erosive Reflux Disease Detection

Stopped: lack of accrual

United States5 participantsStarted 2015-08

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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

What they're measuring

Evaluate non erosive reflux disease (NERD) Symptoms.

Timeframe: 20 weeks

Trial details

NCT IDNCT02788591

SponsorLCMC Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-06

View on ClinicalTrials.gov More Non-erosive Reflux Disease trials