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| Name | Class |
|---|---|
| Peking University Care Luzhong Hospital | OTHER |
| Yuncheng Traditional Chinese Medicine Hospital | OTHER |
| Taierzhuang District People's Hospital | OTHER |
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The researchers collect treatment-naive H.pylori-positive patients from the outpatient clinic. The subjects were randomized to receive a dose and frequency of tetracycline 500mg tid or qid of bismuth quadruple eradication therapy. 6-8 weeks after treatment, the subjects will re-take the 13C-urea breath test. Calculate the eradication rates, adverse reaction rates, patient compliance and cost-effectiveness index of each group.
The researchers collect treatment-naive H.pylori-positive patients from the outpatient clinic. If the subject meets the selection criteria but not the exclusion criteria, and signs an informed consent form, the researchers randomized the subjects in groups: subjects received a dose and frequency of tetracycline 500mg tid or qid of bismuth-containing quadruple eradication therapy. The medication of groups are as follows. 6-8 weeks after the eradication treatment, the subjects will review the 13C-urea breath test, and the researcher records the results.
After all subjects were tested, the eradication rates, adverse reaction rates, patient compliance and cost-effectiveness index of each group were calculated.
According to the course of treatment, it is randomized into a tid treatment group and a qid treatment group. The two groups of bismuth quadruple regimens are the same, as follows:
Tid group: Amoxicillin 1000mg bid+ Tetracycline 500mg tid+ Bismuth + Esomeprazole 20mg bid Qid group: Amoxicillin 1000mg bid+ Tetracycline 500mg qid+ Bismuth + Esomeprazole 20mg bid
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tid group | Experimental | Tid group: Amoxicillin 1000mg bid+ Tetracycline 500mg tid+ Bismuth + Esomeprazole 20mg bid |
|
| Qid group | Active Comparator | Qid group: Amoxicillin 1000mg bid+ Tetracycline 500mg qid+ Bismuth + Esomeprazole 20mg bid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amoxicillin | Drug | Included in quadruple eradication medication. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Eradication rate | Both intention to treat (ITT) and per-protocol (PP) analyses will be used for the assessment of the eradication rates of Helicobacter pylori infections in two groups. The ITT analysis includes all randomly assigned patients who take at least one dose of the study medications. The PP analysis is limited to patients who take over 90% of the study medications and complete follow-up. | Immediately after follow-up check. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of adverse reactions | Rate of adverse reactions | Immediately after follow-up check. |
| Patient compliance | Good compliance is defined as the actual dosage is within the range of 80%-100% of the dosage that should be taken. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xiuli Zuo, MD,PhD | Qilu Hospital of Shandong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhengzhou Central Hospital | Zhengzhou | Henan | China | |||
| Qilu hosipital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28456631 | Background | Hooi JKY, Lai WY, Ng WK, Suen MMY, Underwood FE, Tanyingoh D, Malfertheiner P, Graham DY, Wong VWS, Wu JCY, Chan FKL, Sung JJY, Kaplan GG, Ng SC. Global Prevalence of Helicobacter pylori Infection: Systematic Review and Meta-Analysis. Gastroenterology. 2017 Aug;153(2):420-429. doi: 10.1053/j.gastro.2017.04.022. Epub 2017 Apr 27. | |
| 27707777 |
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| Zhengzhou Central Hospital |
| OTHER |
| Zibo Central Hospital | OTHER_GOV |
This trial is a multi-center, open-label, non-inferiority, randomized controlled trial.
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| Tetracycline tid |
| Drug |
Included in quadruple eradication medication. |
|
| Tetracycline qid | Drug | Included in quadruple eradication medication. |
|
| Bismuth Potassium Citrate | Drug | Included in quadruple eradication medication. |
|
| Colloidal Bismuth Pectin | Drug | Included in quadruple eradication medication. |
|
| Esomeprazole 20mg | Drug | Included in quadruple eradication medication. |
|
| Immediately after follow-up check. |
| Cost-effectiveness index | Ratio of costs to effectiveness | Immediately after follow-up check. |
| Jinan |
| Shandong |
| 257000 |
| China |
| Taierzhuang District People's Hospital | Taierzhuang | Shandong | China |
| Yuncheng Hospital of Traditional Chinese Medicine | Yuncheng | Shandong | China |
| PKUCare Luzhong Hospital | Zibo | Shandong | China |
| Zibo Central Hospital | Zibo | Shandong | China |
| Malfertheiner P, Megraud F, O'Morain CA, Gisbert JP, Kuipers EJ, Axon AT, Bazzoli F, Gasbarrini A, Atherton J, Graham DY, Hunt R, Moayyedi P, Rokkas T, Rugge M, Selgrad M, Suerbaum S, Sugano K, El-Omar EM; European Helicobacter and Microbiota Study Group and Consensus panel. Management of Helicobacter pylori infection-the Maastricht V/Florence Consensus Report. Gut. 2017 Jan;66(1):6-30. doi: 10.1136/gutjnl-2016-312288. Epub 2016 Oct 5. |
| 34836916 | Background | Ding SZ, Du YQ, Lu H, Wang WH, Cheng H, Chen SY, Chen MH, Chen WC, Chen Y, Fang JY, Gao HJ, Guo MZ, Han Y, Hou XH, Hu FL, Jiang B, Jiang HX, Lan CH, Li JN, Li Y, Li YQ, Liu J, Li YM, Lyu B, Lu YY, Miao YL, Nie YZ, Qian JM, Sheng JQ, Tang CW, Wang F, Wang HH, Wang JB, Wang JT, Wang JP, Wang XH, Wu KC, Xia XZ, Xie WF, Xie Y, Xu JM, Yang CQ, Yang GB, Yuan Y, Zeng ZR, Zhang BY, Zhang GY, Zhang GX, Zhang JZ, Zhang ZY, Zheng PY, Zhu Y, Zuo XL, Zhou LY, Lyu NH, Yang YS, Li ZS; National Clinical Research Center for Digestive Diseases (Shanghai), Gastrointestinal Early Cancer Prevention & Treatment Alliance of China (GECA), Helicobacter pylori Study Group of Chinese Society of Gastroenterology, and Chinese Alliance for Helicobacter pylori Study. Chinese Consensus Report on Family-Based Helicobacter pylori Infection Control and Management (2021 Edition). Gut. 2022 Feb;71(2):238-253. doi: 10.1136/gutjnl-2021-325630. Epub 2021 Nov 26. |
| 25741163 | Background | Lv ZF, Wang FC, Zheng HL, Wang B, Xie Y, Zhou XJ, Lv NH. Meta-analysis: is combination of tetracycline and amoxicillin suitable for Helicobacter pylori infection? World J Gastroenterol. 2015 Feb 28;21(8):2522-33. doi: 10.3748/wjg.v21.i8.2522. |
| 15691312 | Background | Marko D, Calvet X, Ducons J, Guardiola J, Tito L, Bory F; GRESCA (Group for Eradication Studies from Catalonia and Aragon). Comparison of two management strategies for Helicobacter pylori treatment: clinical study and cost-effectiveness analysis. Helicobacter. 2005 Feb;10(1):22-32. doi: 10.1111/j.1523-5378.2005.00288.x. |
| 15371921 | Background | Calvet X, Montserrat A, Guell M, Vergara M, Gene E. Ranitidine-bismuth citrate, tetracycline and metronidazole followed by triple therapy as alternative strategy for Helicobacter pylori treatment: a pilot study. Eur J Gastroenterol Hepatol. 2004 Oct;16(10):987-90. doi: 10.1097/00042737-200410000-00006. |
| 29914954 | Background | Xie Y, Zhu Z, Wang J, Zhang L, Zhang Z, Lu H, Zeng Z, Chen S, Liu D, Lv N; the Chinese Study Group on Helicobacter pylori, Chinese Society of Gastroenterology. Ten-Day Quadruple Therapy Comprising Low-Dose Rabeprazole, Bismuth, Amoxicillin, and Tetracycline Is an Effective and Safe First-Line Treatment for Helicobacter pylori Infection in a Population with High Antibiotic Resistance: a Prospective, Multicenter, Randomized, Parallel-Controlled Clinical Trial in China. Antimicrob Agents Chemother. 2018 Aug 27;62(9):e00432-18. doi: 10.1128/AAC.00432-18. Print 2018 Sep. |
| 32348007 | Background | Zhang J, Han C, Lu WQ, Wang N, Wu SR, Wang YX, Ma JP, Wang JH, Hao C, Yuan DH, Liu N, Shi YQ. A randomized, multicenter and noninferiority study of amoxicillin plus berberine vs tetracycline plus furazolidone in quadruple therapy for Helicobacter pylori rescue treatment. J Dig Dis. 2020 May;21(5):256-263. doi: 10.1111/1751-2980.12870. Epub 2020 Jun 9. |
| 39097924 | Derived | Ding YM, Zhang QM, Li RL, Han ZX, Zhao Q, Xu LD, Wang KY, Nan XP, Duan M, Zeng SY, Kong QZ, Wang H, Wu XQ, Zhang N, Li YQ, Zuo XL, Li YY. Tetracycline Three Times Daily Versus Four Times Daily in Bismuth-Containing Quadruple Therapy as the First-Line Treatment of Helicobacter pylori Infection: A Multicenter, Noninferiority, Randomized Controlled Trial. Helicobacter. 2024 Jul-Aug;29(4):e13121. doi: 10.1111/hel.13121. |
| ID | Term |
|---|---|
| D000658 | Amoxicillin |
| D064098 | Esomeprazole |
| ID | Term |
|---|---|
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D001562 | Benzimidazoles |
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