Efficacy of Zinc L-carnosine in Maintaining Remission of Gastroesophageal Reflux Disease

Phase

Condition

Gastroesophageal Reflux Disease (Gerd)

Heartburn (Pediatric)

Esophageal Disorders

Treatment

N/A

Clinical Study ID

NCT03467438

GERDILOR17

Ages > 18
All Genders

Study 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.

Eligibility Criteria

Inclusion

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 impedencemonitoring 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 ofGERD) before entering the study

Exclusion

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 causeallergies)
inconclusive diagnosis of GERD and related symptoms
patients with active H. pylori infection (diagnosed with any of the availabletests)
previous major oesophageal surgery
history of any advanced/relevant organ dysfunction, in particular chronic kidneydisease, 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

Study Design

November 22, 2018

April 01, 2021

Study Description

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).

Connect with a study center

Fondazione IRCCS Policlinico San Matteo
Pavia, 27100
Italy
Active - Recruiting

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