Barrier and protective effects of a newly developed medical device for the treatment of gastroesophageal reflux disease.

Abstract

Background: Gastroesophageal reflux disease is a clinical condition due to the reflux of stomach contents and leading either to erosive or non-erosive disease. Repeated exposure of esophagus to hydrochloric acid, pepsin, bile salts and pancreatic enzymes in gastric contents damages esophageal mucosa, causing inflammation and increased paracellular permeability. A possible therapy for gastroesophageal reflux disease should hinder gastroesophageal reflux and provide esophageal mucosal protection against all aggressive components. The medical device (Med) tested in this study was developed for the treatment of gastroesophageal reflux disease with the aim to achieve a barrier to protect esophageal mucosa against reflux damages and neutralization of the acidic pocket in the stomach.

Methods: The efficacy of Med in forming a protective barrier was performed in vitro using a cellular model of reconstructed human oral epithelium, monitoring its ability to reduce the passage of substances once the formulation was applied, as well as the subsequent reduction in inflammation and toxic effects after exposure to the Triton X-100 stimulus.

Results: The medical device is able of creating an effective barrier at the level of epithelial cells. Its protective action is demonstrated by the ability in reducing toxicity and inflammation induced by an irritant agent.

Conclusions: This work shows the promising effects of Med as a therapeutic solution for managing signs and symptoms associated with gastroesophageal reflux, capable of exerting its function through a physical action without compromising the physiological balance of epithelial cells.