Can Quercetin Increase Claudin-4 and Improve Esophageal Barrier Function in GERD?

Completed · Phase 1

Conditions studied: Gastroesophageal Reflux Disease, GERD, Acid Reflux, Reflux

In brief

Purpose: 1. Determine if oral quercetin increases the expression of claudin-4 in the lining of the esophagus of patients with a diagnosis of gastroesophageal reflux disease (GERD); and 2. Determine whether the increase in claudin-4 by oral quercetin is accompanied by improvement in the barrier function and acid resistance of the lining of the esophagus of patients with a diagnosis of gastroesophageal reflux disease (GERD) If interested, participants will be consented and provided a questionnaire to complete as part of the study. Participants will undergo endoscopy for routine care and will have up to 8 esophageal biopsies (small tissue samples) taken for the research study. After endoscopy, participants will be contacted to begin a 6 week treatment period with study drug (Quercetin, taken twice daily). At the end of the 6 week period, participants will be scheduled to have blood drawn and to have a follow-up endoscopy with biopsies performed for the research study.

Key facts

Study ID

NCT02226484

Run by

University of North Carolina, Chapel Hill

People needed

26

Starts

2014-08-01

Expected to finish

2016-06-01

Last updated by the study team

2016-12-20

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• English speaking
• Able to read, comprehend, and complete the consent form.
• Aged 18 to 80
• Diagnosed with gastroesophageal reflux disease (GERD) by a physician, defined as:
• a. History of heartburn at > 3 times/week for > 4 months AND either: i. Abnormal 24hr-pH monitoring (acid contact time > 4.5% OR ii. Past responsiveness to proton pump inhibitor (PPI) therapy
• Willing to undergo esophageal biopsy, endoscopy, and take study medication.
• Willingness to discontinue or remain off PPIs for the duration of the study (rescue medication use during the study such as antacids and H2 blockers as needed for symptoms is permitted)

You may not qualify if…

• Patients with a medical condition that makes him/her a poor risk for upper endoscopy, conscious sedation, esophageal biopsy or ability to comply with study directives
• Current use of blood thinners such as coumadin, warfarin, heparin and/or low molecular weight heparin, and rivaroxaban (requires discontinuation of medication 5 days prior to and 6 days after EGD)
• Patients with known bleeding disorders
• Patients who are status post partial or complete esophageal resection
• Patients with a history of esophageal or gastric surgery, includes fundoplication, gastric bypass, etc.
• Patients with a history of esophageal varices, esophageal cancer, achalasia, Barrett's esophagus, or eosinophilic esophagitis,
• Current diagnosis of invasive esophageal cancer
• Current use of calcium channel blockers, estradiol, immune suppressive drugs, aspirin, non-steroidal anti-inflammatory drugs (NSAIDs), antibiotics, and/or taxol/paclitaxel
• Pregnant women
• Patients with a history of being intolerant of Quercetin
• Patients with continued moderate or severe heartburn despite use of twice daily PPIs (i.e. refractory to twice daily dosing of PPIs)
• Patients with current active erosive esophagitis (assessed during baseline EGD).
• Patients with a history of erosive esophagitis requiring PPI to treat. However, if patients have a history of erosive esophagitis and have discontinued PPI therapy at least 3 months prior to the baseline EGD, and there is no erosive disease seen during the baseline EGD, then these patients are eligible.
• Patients with significant erosive gastropathy on baseline EGD requiring PPI to treat clinically.

Where it is running

• UNC Chapel Hill — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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