Confocal Endomicroscopy for Non-Erosive Reflux Disease Detection

NCT02788591 | Terminated

• 1 other identifier: CENERDD
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 2

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.

Conditions

Non-erosive Reflux Disease; Gastroesophageal Reflux

Outcome Measures

Primary Outcomes (1)

• Evaluate non erosive reflux disease (NERD) Symptoms.

  Reflux Disease Questionnaire (RDQ)

  20 weeks

Secondary Outcomes (3)

• 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.

  20 weeks

• Compare quality of life in patients with NERD.

  20 weeks

• Compare two medications within each NERD study groups as a subgroup analysis.

  20 weeks

Study Arms (2)

Proton Pump Inhibitor (PPI) Therapy

OTHER

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

Drug: Proton Pump Inhibitor (PPI) Therapy

Sucralfate

OTHER

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

Drug: Sucralfate

Interventions

Proton Pump Inhibitor (PPI) Therapy DRUG

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

Proton Pump Inhibitor (PPI) Therapy

Sucralfate DRUG

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

Also known as: Carafate

Sucralfate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• LCMC Health: lead

Study Sites (2)

Touro Infirmary New Orleans

New Orleans, Louisiana, 70112, United States

Location

University Medical Center New Orleans

New Orleans, Louisiana, 70112, United States

Location

MeSH Terms

Conditions

Non-Erosive Reflux Disease; Gastroesophageal Reflux

Interventions

Proton Pump Inhibitors; Therapeutics; Omeprazole; Esomeprazole; Pantoprazole; Lansoprazole; Sucralfate

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Thioglycosides; Sucrose; Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Officials

• Virendra Joshi, MD

  LCMC Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician, Gastroenterology

Study Record Dates

• First Submitted: March 17, 2016
• First Posted: June 2, 2016
• Study Start: August 1, 2015
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: February 9, 2022

Record last verified: 2021-10

Locations

US (2)