Effect of a Combination of Hyaluronic Acid, Chondroitin Sulphate and Magnesium Trisilicate on Subjects With GastroEsophageal Reflux Disease
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|ClinicalTrials.gov Identifier: NCT03883074|
Recruitment Status : Recruiting
First Posted : March 20, 2019
Last Update Posted : March 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Gastro Esophageal Reflux||Device: hyaluronic acid with chondroitin + sulphate + magnesium trisilicate Device: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Actual Study Start Date :||December 20, 2018|
|Estimated Primary Completion Date :||October 31, 2020|
|Estimated Study Completion Date :||October 31, 2020|
Experimental: GERDOff® Plus
hyaluronic acid with chondroitin + sulphate + magnesium trisilicate Melt in mouth tablets (1100 mg). 1 tablet q.i.d. (three after meals, one before resting) for 3 consecutive weeks. After three weeks of wash-out period,patients will take either placebo or GERDOff® Plus q.i.d. (three after meals, one before resting) for another three weeks.
Device: hyaluronic acid with chondroitin + sulphate + magnesium trisilicate
Melt in mouth tablets (1100 mg)
Other Name: GERDOff Plus
Placebo Comparator: Placebo
Placebo melt in mouth tablets (1100 mg). 1 tablet q.i.d. (three after meals, one before resting) for three consecutive weeks. After three weeks of wash-out period,patients will take either placebo or GERDOff® Plus q.i.d. (three after meals, one before resting) for another three weeks.
tablets with the same aspect of the active device
Other Name: Placebo (for hyaluronic acid with chondroitin + sulphate + magnesium trisilicate)
- Esophageal Impedance [ Time Frame: 3 weeks ]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.
- Esophageal acid exposure [ Time Frame: 3 weeks ]Esophageal acid exposure assessed by 24-hour pH-impedance measurement
- Esophageal permeability [ Time Frame: 3 weeks ]Esophageal permeability assessed by transepithelial electrical resistance
- Microscopic esophagitis [ Time Frame: 3 weeks ]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
- Intercellular spaces [ Time Frame: 3 weeks ]The presence (on endoscopy) and severity of dilated intercellular spaces assessed by transmission electron microscopy.
- The expression of tight junctions [ Time Frame: 3 weeks ]The expression of tight junction proteins at RNA, protein and immunohistochemistry level
- ReQuest Questionnaire score [ Time Frame: 3 weeks ]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
- Esophageal reflux episodes [ Time Frame: 3 weeks ]Total number of reflux episodes and their proximal extent, number of acid reflux events and their duration.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03883074
|Contact: Silvia Porta||+39 email@example.com|
|Contact: Francesca Baldan||+39 firstname.lastname@example.org|
|Leuven, Belgium, box 701, 3000|
|Contact: Jan Tack, Prof. +32 (0)16 345514 email@example.com|
|Principal Investigator:||Jan Tack, Prof.||Universitaire Ziekenhuizen Leuven|