The goal of this randomized, double-blind, single-center clinical trial RELEIF is to learn if medical devices work to decrease symptoms of gastroesophageal reflux disease (GERD) in adults' patients. It will also teach us about the safety, tolerability and improvement of patient's quality of life during and after taking medical device. The main questions it aims to answer are:
* Does medical device relieve reflux symptoms? * Does medical device improve the quality of life of patients with GERD symptoms? Researchers will compare medical device to a placebo (a look-alike substance that contains no drug) to see if medical device works in GERD gastroesophageal reflux disease .
Participants will:
* Take medical device or a placebo every day (4 times a day) for 14 days * Stop taking medical device or placebo for 7 days (wash out period) * Switch the therapy for medical device or placebo for next 14 days * Visit the clinic 4 times during 35 days of this study for checkups and tests * Keep a diary of their symptoms and the number of times they use a medical device * Fill out the form to collect all necessary data.
Diagnosis of gastroesophageal reflux disease based on the presence of typical symptoms such as heartburn and or regurgitation for at least 6 months prior to the screening visit, confirmed by the investigator
Exclusion of erosive reflux disease, Barrett esophagus, and other esophageal abnormalities by upper gastrointestinal endoscopy within the last 6 months, confirmed by the investigator based on medical documentation
No use within 1 month prior to screening of proton pump inhibitors, H2 receptor antagonists, prokinetics such as itopride or prucalopride, GLP1 or GIP analogues, antibiotics, baclofen, tricyclic antidepressants, serotonin and or noradrenaline reuptake inhibitors, and no use within 1 week prior to screening of sucralfate, antacids, or esophageal mucosal protective agents
Presence of gastroesophageal reflux symptoms that negatively impact quality of life, as subjectively reported by the patient and confirmed by the investigator
Women who are breastfeeding or have a positive urine pregnancy test at the baseline visit
Introduction of significant changes in diet or lifestyle during the study period
Presence of alarm symptoms at baseline including dysphagia or odynophagia, unintentional weight loss greater than 5 percent of baseline body weight, signs of gastrointestinal bleeding, anemia, palpable epigastric mass, or persistent vomiting lasting 7 to 10 days
Planned use during the study of antibiotics, probiotics, prebiotics, synbiotics, short chain fatty acids, proton pump inhibitors, H2 receptor antagonists, prokinetics such as itopride or prucalopride, GLP1 or GIP analogues, baclofen, tricyclic antidepressants, serotonin and or noradrenaline reuptake inhibitors, and use within 1 week prior to study start of sucralfate, antacids, or esophageal mucosal protective agents
Cellmedis
Lead sponsor
Medical Network Sp. z o.o.
Collaborator