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| Name | Class |
|---|---|
| E-DA Hospital | OTHER |
| National Taiwan University Hospital Hsin-Chu Branch | OTHER |
| Taipei Veterans General Hospital, Taiwan | OTHER_GOV |
| Kaohsiung Medical University |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sequential therapy for 14 days (S14) | Experimental | 14 day sequential therapy |
|
| bismuth quadruple therapy (Q10) | Active Comparator | Bismuth quadruple therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 14-day sequential therapy | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| changes of gut microbiota | changes of gut microbiota before and after HP eradication by per protocol analysis | 2 weeks, 8 weeks, 1 year |
Inclusion Criteria:
1. H. pylori infected patients naïve to eradication therapies will be eligible in this study.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jyh-Ming Liou, MD, PhD | Contact | dtmed046@pchome.com.tw |
| Name | Affiliation | Role |
|---|---|---|
| Ming-Shiang Wu, MD, PhD | National Taiwan University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chiayi Christian Hospital | Recruiting | Chiayi City | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29846605 | Derived | Liou JM, Chen CC, Fang YJ, Chen PY, Chang CY, Chou CK, Chen MJ, Tseng CH, Lee JY, Yang TH, Chiu MC, Yu JJ, Kuo CC, Luo JC, Hsu WF, Hu WH, Tsai MH, Lin JT, Shun CT, Twu G, Lee YC, Bair MJ, Wu MS; Members of the Taiwan Gastrointestinal Disease and Helicobacter Consortium. 14 day sequential therapy versus 10 day bismuth quadruple therapy containing high-dose esomeprazole in the first-line and second-line treatment of Helicobacter pylori: a multicentre, non-inferiority, randomized trial. J Antimicrob Chemother. 2018 Sep 1;73(9):2510-2518. doi: 10.1093/jac/dky183. |
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| ID | Term |
|---|---|
| C039747 | ribosomal protein S14 |
| D014373 | Tuberculin |
| ID | Term |
|---|---|
| D000942 | Antigens, Bacterial |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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| OTHER |
| Chiayi Christian Hospital | OTHER |
| Mackay Memorial Hospital | OTHER |
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|
| Bismuth quadruple therapy | Drug | D1-D10: (esomeprazole 40mg bid + dibismuth trioxide 120mg qid + metronidazole 500mg tid + tetracycline 500mg qid) for 10 days |
|
|
| 2 weeks |
| changes of antibiotic resistance | changes of antibiotic resistance of E. coli by per protocol analysis | 2 weeks, 8 weeks, 1 year |
| National Taiwan University Hospital, Hsinchu Branch | Recruiting | Hsinchu | Taiwan |
|
| E-DA University Hospital | Recruiting | Kaohsiung City | Taiwan |
|
| Jyh-Ming Liou | Recruiting | Taipei | Taiwan |
|
| Taipei Veteran General Hospital | Recruiting | Taipei | Taiwan |
|
| Mackay Memorial Hospital, Taitung branch | Recruiting | Taitung | Taiwan |
|
| National Taiwan University Hospital, Yun-Lin Branch | Recruiting | Yunlin County | Taiwan |
|
| D000941 |
| Antigens |
| D001685 | Biological Factors |