Status:
COMPLETED
Can Quercetin Increase Claudin-4 and Improve Esophageal Barrier Function in GERD?
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Gastroesophageal Reflux Disease
GERD
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief Summary
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 w...
Detailed Description
Patients must be symptomatic (heartburn) and agree to allow endoscopic biopsies from the lower 5 cm of esophagus for research purposes. If the endoscopy demonstrates non-erosive reflux disease, biopsi...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT02226484
Start Date
August 1 2014
End Date
June 1 2016
Last Update
December 20 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
UNC Chapel Hill
Chapel Hill, North Carolina, United States, 27599