Treatment trial for patients with Barrett’s esophagus

Study ID: R18-3817L

Effect of orally administered zinc on neosquamous esophageal epithelium induced by radiofrequency ablation

Barrett’s esophagus (BE) is a condition that arises from chronic heartburn or gastroesophageal reflux disease and can lead to cancer of the esophagus. The researchers in this study seek to determine if administration of the nutritional supplement zinc gluconate can help people who have been diagnosed with dysplasia in their BE and have undergone radiofrequency ablation (RFA), a nonsurgical procedure that uses a spectrum of energy to produce a highly localized heat-like effect on the tissue in order to destroy the dysplastic Barrett’s region.

Eligible patients must have been diagnosed with BE and have already undergone at least one RFA at least four weeks before enrolling.

Patients are randomized into two study arms. One group receives zinc gluconate lozenges that they will take twice daily for 14 days. The other group receives a placebo. Both groups receive standard care for their dysplastic BE.

The neosquamous epithelium forming after radiofrequency ablation (RFA) has been observed to be a leaky barrier to acid, raising issues for subsequent reappearance of Barrett’s foci, as well as potential neoplastic changes in the squamous epithelium itself. The investigators seek to understand if orally administered zinc gluconate can modify the junctional claudin proteins in neosquamous epithelium resulting in a barrier less leaky to acid (and therefore less subject to acid damage) making for a more stable tissue lining.

Inclusion criteria:

  • 18-85 years old
  • Must have had RFA at least four weeks prior to enrollment

Treatment:

  • Arm 1: Takes two zinc gluconate lozenges (each 13.3 mg zinc) BID for 14 days before follow-up endoscopy
  • Arm 2 (control): Takes two placebo (sodium gluconate) lozenges (each 4.7 mg sodium) BID

Inclusion Snapshot

  • Must have been diagnosed with BE
  • Must have received RFA at least four weeks before trial enrollment

Contact Information

Lankenau Institute for Medical Research trial

Physician Investigator(s)

Study Locations