Abstract
Gastroesophageal reflux disease (GERD) is a common digestive disorder that causes esophagitis and injuries to the esophageal mucosa. GERD symptoms are recurrent during pregnancy and their treatment is focused on lifestyle changes and nonprescription medicines. The aim of this study was to characterize the mechanism of action of a new patented medical device, an oral formulation containing hyaluronic acid, rice extract, and amino acids dispersed in a bioadhesive polymer matrix, by assessing its protective effects in in vitro and ex vivo models of esophageal mucosa damage. Acidic bile salts and pepsin cocktail (BSC) added to CP-A and COLO-680 N esophagus cells were used as an in vitro GERD model to evaluate the binding capacities, anti-inflammatory effects and reparative properties of the investigational product (IP) in comparison to a viscous control. Our results showed that the IP prevents cell permeability and tight junction dysfunction induced by BSC. Furthermore, the IP was also able to down-regulate IL-6 and IL-8 mRNA expression induced by BSC stimulation and to promote tissue repair and wound healing. The results were confirmed by ex vivo experiments in excised rat esophagi through the quantification of Evans Blue permeability assay. These experiments provided evidence that the IP is able to bind to the human esophagus cells, preventing the damage caused by gastroesophageal reflux, showing potential anti-irritative, soothing, and reparative properties.
Highlights
Gastroesophageal reflux disease (GERD) is a condition caused by the excessive spontaneous ascent of gastric contents into the esophagus [1]
In order to evaluate the capability of the investigational product (IP) to bind to the esophageal mucosa, dose response and time course experiments were conducted by adding the IP, stained with bromophenol blue, to a monolayer of CP-A or COLO-680 N
Our results indicated that IP partially prevents the alterations of the Tight Junctions (TJ) induced by bile salts and pepsin cocktail (BSC) treatment (Fig. 3A)
Summary
Gastroesophageal reflux disease (GERD) is a condition caused by the excessive spontaneous ascent of gastric contents into the esophagus [1]. A higher incidence of reflux disease in pregnant women is known and reported to be up to 80 % in the third trimester, both for mechanical reasons related to compressional effects by the gravid uterus on the remaining abdom inal structures, and for alterations of the motility of the lower esopha geal sphincter favored by the particular hormonal pattern [4,5]. The mucosal damage caused by the refluxed gastric material is correlated to the damaging action of its individual components, such as hydrochloric acid, pepsin, and duodenal juice [6,7]. Gastric hydrochloric acid and pepsin cause mucosal damage by affecting the junctions
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