Efficacies of HDDT With or Without Bismuth vs Amoxicillin-metronidazole BQT for First-line H Pylori Eradication
Efficacies of HDDT With or Without Bismuth vs Amoxicillin-metronidazole BQT for First-line H Pylori Eradication
Up to know, three is few large-scale, randomized study prospectively and simultaneously
 comparing the efficacy, adverse effects and patient compliance of high-dose dual therapy
 (HDDT) with or without bismuth versus amoxicillin-metronidazole bismuth quadruple therapy
 (AM-BQT) as first-line regimens for H. pylori eradication.

 The aims of this study are:

 1. to compare the efficacy of HDDT with or without bismuth and AM-BQT as first-line
 regimens for 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 prospective multicenter randomized comparative study will be conducted at the National
 Taiwan University Hospital(NTUH), NTUH Bei-Hu Branch, NTUH Hsin-Chu Branch, Buddhist Tzu Chi
 General Hospital, and Mennonite Christian Hospital in Hua-Lien City. Patients, aged >= 20,
 having H. pylori-positive chronic gastritis with/without peptic ulcers (duodenal or gastric
 ulcers) will be recruited. All undergo endoscopy with biopsy for rapid urease test,
 histology, and bacterial culture before treatment. If the patients did not receive anti-H.
 pylori therapy previously, these patients will be invited to enter this study for evaluating
 the efficacy of these 1st-line regimens.

 A computed generated random numbers sequence will be blocked into three subgroups, say A, B,
 and C. After giving written informed consent, each patient will be randomly allocated, to one
 of three treatment groups:

 group A - HDDT (rabeprazole 20 mg qid + amoxicillin 750 mg qid for 14 days);

 group B - Bis-HDDT (rabeprazole 20 mg qid + amoxicillin 750 mg qid + tripotassium dicitrate
 bismuthate 300 mg qid, for 14 days);

 group C - AM-BQT (rabeprazole 20 mg bid + tripotassium dicitrate bismuthate 600 mg bid +
 amoxicillin 1000 mg bid + metronidazole 500 mg tid , for 14 days);

 All patients will be asked to complete a questionnaire and to record symptoms, drug
 consumption, and diet content 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 C13-urea breath test (UBT). The CYP2C19 genotype of each
 participant will be analyzed by the polymerase chain reaction-based restriction fragment
 length polymorphism (PCR-RFLP) method. A part of participants, at least 30 cases in each
 group, will be invited to join a follow-up program for one year for evaluating the changes or
 evolution of gut microbiota composition, metabolic product, parameters of inflammation and
 immune response.
inclusion criteria: participants having H. pylori related chronic gastritis with/without
 peptic ulcers who are aged greater than 20 years old and are willing to received first-line
 eradication therapy.

 Exclusion criteria:

 1. pregnant or nursing woman;

 2. serious concomitant illness and malignant tumor of any kind;

 3. history of hypersensitivity to test drugs；

 4. serious bleeding during the course of this ulcer;

 5. previous gastric surgery;

 6. receiving bismuth salts, proton pump inhibitors (PPIs), or antibiotics in the previous
 month.