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Gaia Pellegatta,1 Marco Spadaccini,1 Laura Lamonaca,1 Vincenzo Craviotto,1 Ferdinando D’Amico,1 Laura Ceriotti,2 Marisa Meloni,2 Alessandro Repici1 1Humanitas Clinical and Research Center and Humanitas University, Digestive Endoscopy Unit, Division of Gastroenterology, Rozzano, MI, Italy; 2VitroScreen, Milano, ItalyCorrespondence: Gaia PellegattaDigestive Endoscopy Unit, Division of Gastroenterology, Humanitas Research Hospital, Via Manzoni 56, Rozzano, MI 20089, ItalyTel +390282247091Email gaia.pellegatta@humanitas.itPurpose: New medical devices that contain hyaluronic acid (HA) and chondroitin sulphate (CS), with or without antacid components, have been developed for the treatment of gastroesophageal reflux disease (GERD) with the aim of improving oesophageal mucosal defences by creating a film on the oesophageal mucosa and acting as a mechanical barrier against the noxious components of refluxate, both acidic and basic.Methods: The film-forming and protective efficacy of medical device A based on HA and CS plus aluminium hydroxide, device B combining HA and CS with magnesium trisilicate and device C with only the combination of HA and CS was tested on a reconstructed human oesophageal epithelium (HO2E/S/5) as a biological model in 2 different pH environments, neutral and acidic, to mimic realistic conditions. Caffeine penetration kinetics and Lucifer yellow (LY) permeability modifications induced by these products were compared to those induced by a negative control series (saline solution, code NC) and positive control series (white Vaseline, code V) under neutral and acidic pH conditions.Results: Under neutral and acidic pH conditions, compared to the negative control, all the products tested reduced (> 80% and 85– 90%, respectively) the caffeine passage, and no significant difference was observed among the products tested. Under neutral and acidic conditions, the LY permeabilities registered with device A and device C were not different from that registered with the negative control, while an LY flux% increase was calculated after 2 hrs of treatment (21.1%) with device B under acidic conditions.Conclusion: These results confirm the ability of the products tested to interact with the oesophageal epithelium in order to adhere and create a stable protective film for at least 2 hours after their homogeneous distribution on the epithelium surface. Further clinical studies are needed to test these devices in the topical treatment of gastroesophageal reflux symptoms.Keywords: hyaluronic acid, chondroitin sulphate, gastroesophageal reflux disease, antacid, caffeine, Lucifer yellow

BACKGROUND: Proton pump inhibitors (PPIs) are a major breakthrough in the medical management of gastroesophageal reflux disease (GERD). In several patients with non erosive reflux disease symptoms (NERD) the response to PPIs is partial or limited and symptoms relief needs the administration of additional medications. AIM: The aim of this study was to evaluate the effect of a new medical device, based on an oral fixed combination of hyaluronic acid and chondroitin-sulphate (HA+CS), in a bioadhesive carrier, in adults with symptoms of non erosive gas- troesophageal reflux and with a low response to PPIs. PATIENTS AND METHODS: Twenty patients who had experienced heartburn and/or acid regurgitation for at least 3 days during a 7 day run-in period, without endoscopic mucosal breaks, were randomized in a double blind crossover study to receive four daily doses of a fixed oral combination of HA+CS and placebo for 14 days. Relief of cardinal symptoms of GERD was evaluated at the end of each period. RESULTS: A significant greater Sum of Symptoms Intensity Difference, compared to placebo, was observed after HA+CS treatment (-2.7 vs 0.5 - p < 0.01), being both heartburn (-1.6 vs 0.5 - p < 0.03) and acid regurgitation (-1.1 vs 0.1 - p < 0.03) significantly improved by the medical device. A speed of action = = 30 min was significantly more frequently reported by patients during HA+CS administration than with placebo (60% vs 30% - p = 0.05). Total disappearance of symptoms was observed in 50% of the patients compared to 10% during placebo administration (p = 0.01 between group comparison). CONCLUSIONS: A fixed combination of HA+CS has demonstrated to be effective in gas-troesophageal reflux control, with a rapid onset of action. [ABSTRACT FROM AUTHOR]