Sequential Versus Quadruple Therapy in the Second-line Treatment

• Status: Unknown status
• Trial end date: 2020-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Objectives: A recent randomized trial showed that 14-day sequential therapy containing high dose proton pump inhibitor was higher than 95% in the first line treatment. However, whether the 14-day sequential therapy is more effective than 10-day bismuth quadruple therapy remains unknown. Therefore, the investigators aimed to compare the eradication rates and long term re-infection rates of sequential therapy for 14 days versus bismuth quadruple therapy for 10 days in the second line treatment.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Taiwan University Hospital
• Treatments: Amoxicillin; Bismuth; Clarithromycin; Esomeprazole; Metronidazole; Tetracycline

Criteria

Inclusion Criteria:

• H. pylori infected patients who fail from first line standard triple therapy with clarithromycin, amoxicillin, and a proton pump inhibitor will be eligible in this study.

Exclusion Criteria:

Patients will be excluded from the study if any one of the following criteria was present:

• children and teenagers aged less than 20 years,

• history of gastrectomy,

• gastric malignancy, including adenocarcinoma and lymphoma,

• previous allergic reaction to antibiotics (bismuth, metronidazole, levofloxacin, tetracycline) and PPI (esomeprazole),

• contraindication to treatment drugs,

• pregnant or lactating women,

• severe concurrent disease, or

• Unwilling to accept random assignment of subjects.