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.
This will be a multi-center, open labeled, randomized comparative trial Patients: 240 patients with H. pylori infection who failed after first-line therapy will be eligible Interventions: eligible patients will be randomized into one of the two groups Group (A): sequential therapy for 14 days (S14) D1-D7: (esomeprazole 40mg bid + amoxicillin 1000mg bid) for 7 days D8-D14: (esomeprazole 40mg bid + clarithromycin 500mg bid + metronidazole 500mg bid) for another 7 days Group (B): bismuth quadruple therapy for 10 days (Q10) D1-D10: (esomeprazole 40mg bid + dibismuth trioxide 120mg qid + metronidazole 500mg tid + tetracycline 500mg qid) for 10 days Primary End Point: Eradication rate in the second line treatment according to intention to treat (ITT) analysis in the two treatment groups
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
240
Nexium, esomeprazole 40mg bid, 14 days
Nexium, esomeprazole, 40mg bid for 10 days
Day 1-7 amoxicillin (Brand name: Amoxicillin Capsule) 1000mg bid for 7 days
Jyh-Ming Liou
Taipei, Taiwan, Taiwan
RECRUITINGeradication rate in the second-line treatment according to intention to treat (ITT) analysis
Urea breath test will be performed at least 6 weeks after the end of eradication therapy. Successful eradication of H. pylori will be defined as a negative 13C-UBT result. A positive 13C-UBT test will be defined as a delta value of 4 units or greater. All subjects will be asked to stop PPI and H2-blocker for at least two weeks before 13C-UBT.
Time frame: 6 weeks
Incidence of adverse effects in the first line therapy in the two treatment groups
At enrollment, the patients will be informed of the common side effects from the studied drugs and they will be asked to record these symptoms during treatment. A standardized interview and questionnaire will be used to assess the adverse events
Time frame: 2 weeks
Eradication rates in the second line treatment according to per protocol (PP) analysis
Urea breath test will be performed at least 6 weeks after the end of eradication therapy. Patients not follow the protocol will be excluded for PP analysis.
Time frame: 6 weeks
Changes of gut microbiota in the two treatment groups
the stool specimens before, 2weeks after, 8 weeks after, and 1 year after the treatment will be collected for gut microbiota analysis
Time frame: 2 weeks, 8 weeks, and 1 year
Re-infection rate one year after eradication therapy
Urea breath test will be performed 1 year after the end of eradication therapy.
Time frame: 1 year
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Klaricid-XL, clarithromycin, 500mg, bid, for 7 days, (day 8-14)
Flagyl, metronidazole, 500mg bid, for 7 days (day 8-14)
KCB F.C. TABLETS, dibismuth trioxide 120mg qid for 10 days
Flagyl, metronidazole 500mg tid for 10 days
Tetracycline (Brand name: Tetracycline Capsule ) 500mg qid for 10 days