Efficacies of HDDT With or Without Bismuth vs Amoxicillin-metronidazole BQT for First-line H Pylori Eradication

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Taiwan University Hospital
• Collaborator: Ministry of Science and Technology, Taiwan
• Treatments: Amoxicillin; Anti-Bacterial Agents; Antibiotics, Antitubercular; Bismuth; Metronidazole; Proton Pump Inhibitors; Rabeprazole

Criteria

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.