2017-08-012024-05-18https://scholars.lib.ntu.edu.tw/handle/123456789/701872Helicobacter pylori (H. pylori) infection is highly prevalent worldwide and has been implicated in a variety of important gastrointestinal disorders. The trend to antibiotic resistance is rising. Consequently, the eradication rate of triple therapy for H. pylori infection have been rapidly falling to below 80% in most area and alternative treatments are required. Bismuth-containing quadruple therapy (BQT) has been recommended for a standard rescue treatment after failed standard first-line therapy. The amoxicillin-based dual therapy, with a very rare prevalence of primary and secondary antibiotic resistance, has the potential to be an optimal first-line and rescue anti-Helicobacter pylori regimen Since most PPIs are mainly metabolized by CYP2C19, thus, it should be beneficial to use higher PPI doses for patients who are CYP2C19 EMs. Recently, we have completed a large-scale randomized controlled trial. Our results show that high-dose dual therapy (HDDT) with rabeprazole 20 mg and amoxicillin 750 mg four times daily for 2 weeks cures about 90% of treatment-experienced patients and is superior to sequential therapy or levofloxacin-containing triple therapy. Recently, it is suggested that H. pylori inducing persistent inflammation in the stomach may affect the ecosystem of gut microbiota. However, up to now, the effect of H. pylori eradication on the ecosystem of gut microbiota in Taiwan is still scarce. The aims of this study are: 1) to compare the efficacy of HDDT, and BQT as rescue regimen in H. pylori eradication; 2) to compare the patient adherence and adverse effects of these treatment regimens; 3) to investigate factors that may influence H. pylori eradication by these treatment regimens; 4) to identify the effect of H. pylori eradication on the evolution of ecosystem of microbiota, and inflammatory parameters. This is a prospective multicenter randomized comparative study. All treatment experienced undergo endoscopy with biopsy for rapid urease test, histology, and bacterial culture before treatment. Each patient will be randomly allocated to one of two treatment groups: group A – HDDT (rabeprazole 20 mg qid + amoxicillin 750 mg qid for 14 days); group B – BQT (rabeprazole 20 mg bid + tripotassium dicitrate bismuthate 300 mg qid + metronidazole 250 mg qid + tetracycline 500 mg qid for 10 days); All patients will be asked to complete a questionnaire and to record symptoms and drug consumption daily during the treatment period. Post-treatment, the patients will be followed up at the Outpatients Clinic to investigate patient adherence and adverse effects of treatment. Four to eight weeks after termination of treatment, H. pylori infection status will be examined by the 13C-urea breath test (UBT). The CYP2C19 genotype of each participant will be analyzed. Totally, we should enroll about 440 cases, 220 cases in each group of study, suppose 10% of cases will be dropped out. We will also evaluate the effect of H. pylori eradication in the difference or changes of gut microbiota composition, metabolic product, parameters of inflammation, immune response, and cell death pathway in the patients.Efficacy of High-Dose Dual Therapy Versus Bismuth-Containing Quadruple Therapy for the Rescue Treatment of Helicobacter Pylori Infection – a Prospective, Randomized, Comparative Study