Clinical trial NCT03883074: Effect of a Combination of Hyaluronic Acid, Chondroitin Sulphate and Magnesium Trisilicate on Subjects With GastroEsophageal Reflux Disease
Official title: Effect of a Combination Oral Formulation of Hyaluronic Acid With Chondroitin Sulphate and With Magnesium Trisilicate on Mucosal Integrity and Reflux Exposure in Subjects With Gastro-Esophageal Reflux Disease Not Currently Treated With a Proton Pump Inhibitor: a Double-Blind, Placebo-Controlled, Randomized, Crossover Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastro Esophageal Reflux
Lead sponsor: SOFAR S.p.A.
Sponsor class: INDUSTRY
First posted: 2019-03-20
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Esophageal Impedance
timeFrame: 3 weeks
Secondary outcomes:
measure: Esophageal acid exposure
timeFrame: 3 weeks
measure: Esophageal permeability
timeFrame: 3 weeks
measure: Microscopic esophagitis
timeFrame: 3 weeks
measure: Intercellular spaces
timeFrame: 3 weeks
measure: The expression of tight junctions
timeFrame: 3 weeks
measure: ReQuest Questionnaire score
timeFrame: 3 weeks
measure: Esophageal reflux episodes
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZLeuven
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Jan Tack, Prof.
role: PRINCIPAL_INVESTIGATOR
References: