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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GERDOff® Plus | Experimental | 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. |
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| Placebo | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hyaluronic acid with chondroitin + sulphate + magnesium trisilicate | Device | Melt in mouth tablets (1100 mg) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Esophageal acid exposure | Esophageal acid exposure assessed by 24-hour pH-impedance measurement | 3 weeks |
| Esophageal permeability | Esophageal permeability assessed by transepithelial electrical resistance |
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Inclusion Criteria:
Exclusion Criteria:
Patients suffering from gastrointestinal diseases other than GERD
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| Name | Affiliation | Role |
|---|---|---|
| Jan Tack, Prof. | Universitaire Ziekenhuizen KU Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZLeuven | Leuven | box 701, 3000 | Belgium |
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| Placebo | Device | tablets with the same aspect of the active device |
|
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| 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 | 3 weeks |
| Intercellular spaces | The presence (on endoscopy) and severity of dilated intercellular spaces assessed by transmission electron microscopy. | 3 weeks |
| The expression of tight junctions | The expression of tight junction proteins at RNA, protein and immunohistochemistry level | 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 | 3 weeks |
| Esophageal reflux episodes | Total number of reflux episodes and their proximal extent, number of acid reflux events and their duration. | 3 weeks |
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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