A Phase 4 interventional study of 14-day sequential therapy and Bismuth quadruple therapy in Helicobacter, sponsored by National Taiwan University Hospital. Status unknown at 7 sites in Taiwan. Open to participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-05-17.
Sponsored by National Taiwan University Hospital · Phase 4, Interventional, and Treatment
The investigators aimed to
Helicobacter pylori infection has been shown to be associated with the development of gastric cancer and peptic ulcer diseases. Eradication of H. pylori infection reduces the risk of gastric cancer and recurrence of peptic ulcer disease. However, the eradication rate of clarithromycin-based triple therapy has been declining in recent years, probably related to the increasing resistant rate to clarithromycin. Sequential therapy for 10 days has been shown to be more effective than triple therapy for 7 and 10 days. The investigators further demonstrated that sequential therapy given for 14 days was superior to triple therapy given for 14 days. Recently, the investigators also found that bismuth quadruple therapy given for 10 days appeared to be more effective than triple therapy given for 14 days in the first line therapy. However, whether sequential therapy given for 14 days is more effective than bismuth quadruple therapy or triple therapy for 14 days remains unknown.
National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
14 day sequential therapy
Drug: 14-day sequential therapy
Bismuth quadruple therapy
Drug: Bismuth quadruple therapy
D1-D7: (esomeprazole 40mg qid + amoxicillin 500mg qid) for 7 days D8-D14: (esomeprazole 40mg qid + clarithromycin 500mg bid + metronidazole 500mg bid) for another 7 days
Also known as: S14
D1-D10: (esomeprazole 40mg bid + dibismuth trioxide 120mg qid + metronidazole 500mg tid + tetracycline 500mg qid) for 10 days
Also known as: Q10
Eradication rate: determined by urea breath test (13C-UBT, according to ITT analysis)
No eradicated divided by total cases by intention to treat analysis. 13C-UBT will be used to determine the H. pylori status at least 6 weeks after completion of treatment. A delta value of \> 4 units will be defined as positive for H. pylori infection as our previous studies.
Time frame: 6 weeks
adverse effect: occurrence of any adverse effect during the treatment
adverse effects related to treatment by per protocol analysis. The patients will be informed of the common side effects from the studied drugs prior to therapy. They will also be asked to record these symptoms during treatment. A standardized interview at the outpatient clinic at the end of treatment will be arranged. The adverse events and compliance will be assessed by the research staffs with pre-defined case report form.
Time frame: 2 weeks
changes of antibiotic resistance
changes of antibiotic resistance of E. coli by per protocol analysis
Time frame: 2 weeks, 8 weeks, 1 year
changes of gut microbiota
changes of gut microbiota before and after HP eradication by per protocol analysis
Time frame: 2 weeks, 8 weeks, 1 year
Plan to share: No
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National Taiwan University Hospital