Benesco voor reflux symptomen

Rationale: Gastroesophageal reflux disease (GERD) is one of the most common gastro-intestinal disorders with an estimated prevalence of 7%-33% worldwide. Although proton pump inhibitor (PPI) therapy forms the mainstay of GERD management, approximately one-third of the patients experience persistent symptoms despite daily PPI use. Moreover, a subset of patients does not want to use PPI and seeks for alternative therapies because of assumed side effects such as dementia, osteoporosis and pneumonia. Given the high prevalence of GERD, reflux symptoms represent a significant clinical problem and press a high burden on current health care. Esophageal mucosal barrier function, as the underlying cause of esophageal hypersensitivity, is considered a potential therapeutic target in reflux disease. benescoTM is an over-the-counter nutritional supplement containing quercetin, a naturally-occurring flavonoid that has a long history of consumption as part of the normal human diet. Previous studies demonstrated that oral quercetin supports esophageal barrier function and acid resistance. However to date, the clinical efficacy on reflux symptoms and the effect on acid sensitivity in humans has not been studied yet. If we are able to demonstrate the clinical effect of benescoTM for reduction of reflux symptoms and confirm its role in supporting esophageal barrier function and acid perception in humans, it will support the use of benescoTM as a valuable natural alternative to PPI-treatment. Objective: to assess the effect of benescoTM on reflux symptoms (part A) and secondly on esophageal sensitivity to acid and mucosal barrier function (part B). Study design: A single centre, double-blind placebo-controlled randomized trial Study population: 108 patients with reflux symptoms (100 in part A; 8 in part B) Intervention: Part A: during the study period of 6 weeks, patients will receive 3 times daily 200 mg of benescoTM or a placebo. Patients will fill out symptom questionnaires at baseline and every week for the total duration of the study (6 weeks) Moreover, patients will report a daily symptom diary. Eight reflux patients are asked to participate in the mechanistic intervention study (study part B). These subjects will undergo additional testing at baseline and after 6 weeks of benescoTM by means of upper endoscopy with biopsy sampling, electrical tissue impedance spectroscopy and an acid perfusion test. Main study parameters/endpoints: the primary outcome is treatment success, defined as a reduction in symptoms of 50%. Secondary outcomes include reduction in symptom frequency and symptom severity (using a symptom diary). Nature and extent of the burden and risks associated with participation, benefit and group relatedness: For the treatment period of six weeks, subjects will fill out short symptom diaries and weekly symptom questionnaires (on six separate occasions). There will be one study visit, which can be either a physical visit to the hospital or a video conference call. benescoTM is an over-the-counter nutritional supplement containing quercetin. Numerous clinical studies have proven good safety of quercetin and no compound-related adverse effects or evidence for toxicity have been found. The subgroup of subjects that will participate in the part B study, will undergo two upper endoscopies with biopsy sampling and two esophageal acid perfusion tests. Both endoscopy and acid perfusion test cause mild discomfort. Sedation can be provided on demand. Risk of perforation or bleeding of biopsy taking is smaller than 1/10000 endoscopies. Participants will be compensated financially for participation in the study and the findings could help treat future patients with similar complaints.

We hypothesize that benesco TM reduces symptoms, esophageal acid sensitivity and permeability in patients with reflux symptoms

6 weeks

Part A: during the study period of 6 weeks, patients will receive 3 times daily 200 mg of benescoTM or a placebo. Patients will fill out symptom questionnaires at baseline and every week for the total duration of the study (6 weeks) Moreover, patients will report a daily symptom diary. Eight reflux patients are asked to participate in the mechanistic intervention study (study part B). These subjects will undergo additional testing at baseline and after 6 weeks of benescoTM by means of upper endoscopy with biopsy sampling, electrical tissue impedance spectroscopy and an acid perfusion test.