An interventional study of Proton Pump Inhibitor (PPI) Therapy and Sucralfate in Non-erosive Reflux Disease and Gastroesophageal Reflux, sponsored by LCMC Health. Terminated at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-09.
Sponsored by LCMC Health · Not applicable, Interventional, and Diagnostic
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.
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.
1,067 studies on the registry are indexed under Gastroesophageal Reflux; 188 are open to participants now.
This study's enrollment of 5 is below the median of 72 across 712 interventional studies indexed under Gastroesophageal Reflux.
Browse Gastroesophageal Reflux studies →LCMC Health is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
2x daily Proton Pump Inhibitor (PPI) Therapy for 8 weeks
Drug: Proton Pump Inhibitor (PPI) Therapy
4x daily Sucralfate slurry, 1g, for 8 weeks
Drug: Sucralfate
Subject will take a proton pump inhibitor (PPI) of their choice (Omeprazole, Esomeprazole, Pantoprazole, or Lansoprazole) 2 times a day for 8 weeks.
Also known as: Omeprazole, Esomeprazole, Pantoprazole, Lansoprazole
Subject will take Sucralfate 4 times a day for 8 weeks.
Also known as: Carafate
Evaluate non erosive reflux disease (NERD) Symptoms.
Reflux Disease Questionnaire (RDQ)
Time frame: 20 weeks
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.
A 3 minute video recording of microscopic images starting with the injection of the fluorescein will be captured during the time of endoscopy. The goal is also to see if the time to seeing fluorescein in the intracellular spaces correlates with a diagnosis of NERD. Time, measured in seconds, to first visualization of intrapapillary loops and intercellular gaps and fluorescein leak will be obtained and assess by trained endoscopists.
Time frame: 20 weeks
Compare quality of life in patients with NERD.
Quality of life questionnaire (SF-36)
Time frame: 20 weeks
Compare two medications within each NERD study groups as a subgroup analysis.
Categorical and binary demographics and outcomes will be assessed through a likelihood-ratio chi square test or a Fischer's exact test.Continuous outcomes, including time to fluorescein intracellular, will be assessed through a Student's t test or Wilcoxon rank sum, if the distribution of particular continuous variables is non-normal, tested through a Shapiro-Wilk statistic. Statistical significance will be determined at p values less than 0.05.
Time frame: 20 weeks
Plan to share: Undecided
No publications or documents are linked to this record.
This study is terminated, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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