Poliprotect®, a Medical Device Made of Substances, Potently Protects the Human Esophageal Mucosa Challenged by Multiple Agents: Evidence from In Vitro and Ex Vivo Electrophysiological Models

Int J Mol Sci. 2025 Jan 18;26(2):791. doi: 10.3390/ijms26020791.

Abstract

The integrity of esophageal epithelial cells in patients with gastroesophageal reflux disease (GERD) or GERD-like symptoms is the first mechanism of protection to decrease the sensitivity to gastric reflux and heartburn symptoms. We investigated the protective effects of Poliprotect® (PPRO), a CE-marked medical device, on esophageal epithelial integrity using in vitro and ex vivo models. In vitro, the protective effects of PPRO were tested on Caco-2 cells. PPRO demonstrated safety and protection against oxidative damage induced by hydrogen peroxide. It also preserved epithelial integrity by maintaining transepithelial electrical resistance (TEER) against damage from calcium removal or bile acid exposure (taurodeoxycholic acid, TDCA). Ex vivo, esophageal biopsies from patients subjected to endoscopy were mounted in Ussing chambers and exposed to damaging agents (HCl or HCl + TDCA). Untreated biopsies (control) showed significant loss of epithelial resistance (up to -33%). In contrast, low concentrations of PPRO (50-100 µg/mL) provided strong protection against these damages (p < 0.001), even after 60 min of washing. Histological analysis confirmed the barrier-enhancing effect of PPRO. Overall, PPRO effectively protected the esophageal epithelium from damage in both models, suggesting its potential role in alleviating GERD or GERD-like symptoms by strengthening mucosal barriers and reducing epithelial sensitivity to reflux.

Keywords: Ussing chambers; electrophysiological protection; esophageal mucosal integrity; gastroesophageal reflux disease; medical device made of substances; synergistic molecular complex.

MeSH terms

  • Caco-2 Cells
  • Electric Impedance
  • Epithelial Cells / drug effects
  • Epithelial Cells / metabolism
  • Esophageal Mucosa* / drug effects
  • Esophageal Mucosa* / metabolism
  • Esophageal Mucosa* / pathology
  • Esophagus / drug effects
  • Esophagus / pathology
  • Gastroesophageal Reflux* / drug therapy
  • Humans
  • Hydrogen Peroxide / pharmacology
  • Male
  • Oxidative Stress / drug effects
  • Protective Agents / pharmacology

Substances

  • Hydrogen Peroxide
  • Protective Agents