efficacy of zinc l-carnosine in maintaining remission of gastroesophageal reflux disease

Conditions: Gastroesophageal Reflux Disease

Summary: gastroesophageal reflux disease (gerd), according to the montreal classification, is defined as a condition that develops when the reflux of stomach contents causes troublesome symptoms and/or complications. gerd, as clinically defined by the presence of heartburn, acid regurgitation, or both, at least once a week, is a global disease, being one of the most common gastroenterological disorders worldwide that affects roughly 10-30% of the general population in the western world and less than 10% of the asian populations. gerd complications may be life threatening and range from reflux esophagitis to barrett's oesophagus and, eventually, adenocarcinoma. zinc l-carnosine (brand name in italy: hepilor®) is a chelate compound of zinc and l-carnosine, with a long history of more than 20 years of clinical use in japan that has recently become available in italy for the treatment of any condition that requires a mucosal protection and mucosal repair within the gastrointestinal tract, thus including gerd. however, clinical data in western countries are limited. the aim of this double-blind, placebo-controlled study is to demonstrate the efficacy of zinc-l-carnosine in maintaining gerd clinical remission during a 12-week treatment.

the investigators hypothesise that zinc-l-carnosine is able to maintain gerd remission, thus improving the quality of life of these patients. a comparison with a placebo is necessary, as gerd symptoms may be heavily influenced by the nocebo/placebo effect. this is a post-marketing, single center, double-blind, and randomized, placebo-controlled, parallel study. patients with gerd treated with an 8-week cours of proton pump inhibitors will be randomize and receive either zinc-l-carnosine or placebo for 12-week. gerd symptoms will be assessed with a questionnaire (modified gerd questionnaire by locke) monthly for 12 weeks and after a 4-week wash-out. also, quality of life will be assessed at baseline and at 12 weeks with the 36-item short form survey (sf-36).

Eligibility criteria:
inclusion criteria: * written informed consent to participate * be male or female patients ≥ 18 years old, with an established diagnosis of gerd * have a diagnosis of gerd that is established clinically in case of typical symptoms (heartburn and acid regurgitation ≥ once weekly) or with 24-hour esophageal impedence monitoring in case of atypical symptoms not responsive to proton pump inhibitors (ppis) or in case of unclear diagnosis * have been treated with an 8-week course of ppi (as per gold-standard treatment of gerd) before entering the study exclusion criteria: * any medical condition that requires chronic therapy with ppis or h2 antagonists; anti-acid agents must be discontinued within the study period * oesophageal motility disorders * allergy or intolerance to hepilor® (it contains parahydroxybenzoate that may cause allergies) * inconclusive diagnosis of gerd and related symptoms * patients with active h. pylori infection (diagnosed with any of the available tests) * previous major oesophageal surgery * history of any advanced/relevant organ dysfunction, in particular chronic kidney disease, chronic liver disease of any aetiology, hearth failure * any concomitant medical condition with a poor prognosis (\< 3 months) * pregnant females * inability to conform to the protocol * treatment with any investigational drug within the previous 3 months * any subject not able to express/understand the informed consent

Keywords: heartburn pyrosis regurgitation