Study ID: R18-3817L
Effect of zinc on esophageal and duodenal epithelial junctional seals
Researchers seek to understand if the micronutrient zinc gluconate can tighten the spaces between cells, an effect that may lead to improved outcomes for patients who have been diagnosed with various esophageal disorders, including Barrett's esophagus (BE), gastrointestinal reflux disease (GERD), and esophageal cancer, as well as disorders of the duodenum, such as inflammatory bowel disease (IBD) and celiac disease.
Eligible patients for this trial must have been diagnosed with BE.
Patients are randomized into two study arms. One group receives zinc gluconate lozenges and will take four per day. The other group receives a placebo. Both groups receive standard care for their conditions. Participants are monitored for three years for disease progression.
The purpose of this study is to determine if orally administered zinc can modify the epithelial junctional seals of the esophagus and duodenum in situ. The goal is to modify the junctional seals and improve barrier function of the tissue.
- Arm 1: Takes zinc gluconate lozenges (each 13.3 mg zinc) four times per day (for a total daily dose of 53.2 mg zinc) for 14 days before follow-up endoscopy
- Arm 2 (control): Takes two placebo (sodium gluconate) lozenges (each 4.7 mg sodium) BID
- Must have been diagnosed with BE
- Must be between the ages of 18 and 80
- Must not be taking any medications that can interfere with zinc