Effect of a Combination of Hyaluronic Acid, Chondroitin Sulphate and Magnesium Trisilicate on Subjects With GastroEsophageal Reflux Disease

SOFAR S.p.A.21 enrolled

Overview

The aim of this study is to investigate whether a 3-week treatment with an oral melt in mouth medical device, made up with hyaluronic acid, chondroitin sulphate and magnesium trisilicate, can lead to a reduction of Gastroesophageal Reflux Disease symptoms and to an improvement of the integrity of esophageal mucosa in patients who are to experiencing esophagus symptoms. The study is a randomized, double-blind cross-over placebo controlled study. Every patient will get both the active study device during one study period and placebo during another another period.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Gastro Esophageal Reflux

Interventions

hyaluronic acid with chondroitin + sulphate + magnesium trisilicate

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Males and females, age 18 to 75 years * GERD as defined by an acid exposure time \>4% on pH/impedance monitoring and/or esophagitis LA grade A or B on endoscopy * Heartburn at least twice per week over the last 1 month * ReQuest Symptoms sum score \>3,37 at screening * GERD patients not treated with a PPI in the previous 2 months * Subjects capable of understanding and be willing to provide signed and dated written voluntary informed consent Exclusion Criteria: * Patients suffering from gastrointestinal diseases other than GERD * Esophagitis LA grade C or D or Barrett's esophagus on endoscopy * Impaired kidney or liver function * Significant cardiac, pulmonary or psychiatric comorbidity as judged by the investigator * Medication use (including NSAIDS) that may interfere with GERD symptom assessment within 2 weeks before the start of the study or during the study * Pregnancy or breast-feeding * Females of childbearing potential in the absence of effective contraceptive methods * History of/or current psychiatric illness that would interfere with ability to comply with protocol requirements or give informed consent * History of alcohol or drug abuse that would interfere with ability to comply with protocol requirements * Treatment with any investigational drug within the previous 30 days * Active malignancy of any type, or history of cancer, including solid tumors and hematological malignancies (except patients with malignancies that have been surgically removed and/or with no evidence of recurrence for at least five years before study enrolment) * Inability to conform to protocol procedures

Outcomes

Primary Outcomes

Esophageal Impedance

Change between groups in baseline impedance value. Impedance baseline values will be assessed in two steady periods of 30 seconds at the beginning and at the end of consecutive time windows of 30 minutes, 60 minutes.

Time frame: 3 weeks

Secondary Outcomes

Esophageal acid exposure

Esophageal acid exposure assessed by 24-hour pH-impedance measurement

Time frame: 3 weeks

Esophageal permeability

Esophageal permeability assessed by transepithelial electrical resistance

Time frame: 3 weeks

Microscopic esophagitis

Microscopic esophagitis evidence at endoscopy assessed by Esohisto score. The score assesses the severity of esophagitis through a score for each parameter ranging from 0 to 2 (0=normal, 2=severe). Parameters are: Basal cell layer hyperplasia; Papillary elongation; Dilated intercellular spaces; Intraepithelial eosinophils; Intraepithelial neutrophils; Intraepithelial mononuclear cells

Time frame: 3 weeks

Intercellular spaces

The presence (on endoscopy) and severity of dilated intercellular spaces assessed by transmission electron microscopy.

Time frame: 3 weeks

The expression of tight junctions

The expression of tight junction proteins at RNA, protein and immunohistochemistry level

Time frame: 3 weeks

ReQuest Questionnaire score

Change in ReQuest score for GERD symptoms severity evaluated through ReQuest Questionnaire. ReQuest is a self-assessed, dimension-orientated scale designed to evaluate the treatment response in patients suffering from erosive GERD. It assesses seven dimensions of GERD (acid complaints, upper abdominal/stomach complaints, lower abdominal/ digestive complaints, nausea, sleep disturbances, other complaints and general well-being). The intensity is measured on a 100-mm visual analogue scale and the frequency (except general well-being) on a 7-point Likert scale, ranging from 0 to more than 10 times per day. It asks for the occurrence of symptom descriptions known to be typical of the corresponding dimension

Time frame: 3 weeks

Esophageal reflux episodes

Total number of reflux episodes and their proximal extent, number of acid reflux events and their duration.

Time frame: 3 weeks

Effect of a Combination of Hyaluronic Acid, Chondroitin Sulphate and Magnesium Trisilicate on Subjects With GastroEsophageal Reflux Disease

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes