Clinical trial: Can Quercetin Increase Claudin-4 and Improve Esophageal Barrier Function in GERD? (NCT02226484)

Eligibility criteria:
Inclusion Criteria:

          -  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 Criteria:

          -  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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years

Patient description (medical language): A 48-year-old man comes to the office complaining of heartburn and acid reflux.  He has taken over-the-counter antacids but sees no relief.  Other medical history is unremarkable.  The patient does not use tobacco, alcohol, or illicit drugs.  Vital signs are within normal limits.  BMI is 31 kg/m2.  Physical examination is  positive for mild tenderness in upper stomach. Chest x-ray shows an air-fluid opacity behind the heart.  A barium swallow study reveals approximately 1/3 of the stomach herniating through the esophageal hiatus.

Patient description (patient's own words): I went to my doctor's office because of a non-stop heartburn and some acid reflux. I took over-the-counter medications, but it keeps going strong! I don't smoke, take drugs or drink alcohol, I'm healthy! The doctor took my vitals, which turned out normal. My BMI is 31, which might be a bit too much for a 48-year-old guy like me. They examined my stomach and found a mild tenderness in the upper part. I also did some X-rays, and they found out that I have an air-fluid opacity behind my heart. I did another X-ray, and it turns out that a part of my stomach went up my chest through a hole in my diaphragm!

Does the patient match the trial criteria? 0