Acid reflux, known also as gastroesophageal reflux disease (GERD), is a condition where stomach acid flows up into the esophagus, and sometimes even into the throat and mouth. The irritating acid can cause many different annoying symptoms including heartburn, regurgitation, pain in the chest and acid taste.
When stomach acids repeatedly back up into the esophagus, they can injure its sensitive lining and as a result, symptoms may eventually become more severe. Approximately half of all adults will report reflux symptoms at some time in their life.1
Poorly treated GERD has a significant impact on patients’ lives and can lead to reduced physical and social activity. The most common symptom of GERD is a burning sensation in the chest known as heartburn.
Heartburn is an unpleasant condition which can be extremely painful impacting daily activities and sleep more severely than those with regurgitation predominant.2 A randomised, double- blind, parallel group, placebo-controlled study recently published in European Journal of Gastroenterology and Hepathology, has found Giellepi’s medical device RefluG Isorepair to significantly reduce the severity of heartburn (Fig.1) in as little as 7 days in subjects suffering from moderate GERD symptoms. In addition, the group receiving the active treatment, experienced 68% redution in total symptom score at the end of 2-week supplementation.3
RefluG Isorepair is a novel patented medical device in liquid sachets indicated for heartburn and other symptoms associated to reflux which protects the esophageal mucosa from refluxed acid and pepsin while supporting the wound repair. The perceived effect of RefluG Isorepair, as effective in reducing, in particular, not only heartburn but also the frequency of regurgitation, retrosternal pain and acid taste observed during the study, underlies in its unique non-systemic mode of action. A mechanistic study conducted at University of Trieste, showed that RefluG Isorepair is able to create a physical protective barrier on the surface of the esophageal mucosa providing protection against refluxate and promoting tissue regeneration.4
From these results the researchers concluded RefluG Isorepair may have a potential as a treatment strategy for subjects with mild and moderate GERD symptoms. A new multicentric RCT is underway to assess the efficacy of RefluG Isorepair paired to a standard dose of Proton Pump Inhibitor in improving symptoms in those with non-erosive reflux disease or grade A esophagitis.
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References
- Locke GR, Talley NJ, Fett SL, Zinsmeister AR, Melton LJ. Prevalence and clinical spectrum of gastroesophageal reflux: a population-based study in Olmsted County, Minnesota. Gastroenterology. 1997;112:1448–1456.
- Lee SW, Lien HC, Lee TY, Yang SS, Yeh HJ, Chang CS. Heartburn and regurgitation have different impacts on life quality of patients with gastroesophageal reflux disease. World J Gastroenterol. 2014; 20(34):12277–12282.
- Ribaldone DG, Rajesh P, Chandradhara D, Astegiano M, Pellicano R. A randomized, double-blind, placebo-controlled pilot study to evaluate the efficacy and tolerability of a novel oral bioadhesive formulation for the treatment of nonerosive reflux disease-related symptoms. Eur J Gastroenterol Hepatol. 2021;32(2):163-170.
- Agostinis C, Bossi F, Mangogna A, Balduit A, Pacor M, Giacomello E, Belmonte B, Greco D, Rodolico V, Voinovich D, De Seta F, Ricci G, Bulla R. Protective and regenerative effects of a novel medical device against esophageal mucosal damage using in vitro and ex vivo models. Biomed Pharmacother. 2020; 131:110752.