Sequential Therapy Versus Quadruple Therapy in H. Pylori Eradication
NCT ID: NCT03156855
Last Updated: 2017-05-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
620 participants
INTERVENTIONAL
2015-09-30
2019-12-31
Brief Summary
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1. 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 first line and second line treatment
2. assess the impact of antibiotic resistance and CYP2C19 polymorphism on the eradication rate of these regimens
3. assess the impact of these eradication regimens on the antibiotic resistance and microbiota of the gut flora
4. assess the impact of eradication therapy on the metabolic factors
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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sequential therapy for 14 days (S14)
14 day sequential therapy
14-day sequential 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
bismuth quadruple therapy (Q10)
Bismuth quadruple therapy
Bismuth quadruple therapy
D1-D10: (esomeprazole 40mg bid + dibismuth trioxide 120mg qid + metronidazole 500mg tid + tetracycline 500mg qid) for 10 days
Interventions
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14-day sequential 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
Bismuth quadruple therapy
D1-D10: (esomeprazole 40mg bid + dibismuth trioxide 120mg qid + metronidazole 500mg tid + tetracycline 500mg qid) for 10 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. history of gastrectomy,
3. gastric malignancy, including adenocarcinoma and lymphoma,
4. previous allergic reaction to antibiotics (bismuth, amoxicillin, metronidazole, clarithromycin, tetracycline) and PPI (esomeprazole),
5. contraindication to treatment drugs,
6. pregnant or lactating women,
7. severe concurrent disease,
8. concomitant use of clopidogrel, or (9) Unwilling to accept random assignment of subjects
20 Years
ALL
Yes
Sponsors
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E-DA Hospital
OTHER
National Taiwan University Hospital Hsin-Chu Branch
OTHER
Taipei Veterans General Hospital, Taiwan
OTHER_GOV
Kaohsiung Medical University
OTHER
Chiayi Christian Hospital
OTHER
Mackay Memorial Hospital
OTHER
National Taiwan University Hospital
OTHER
Responsible Party
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Principal Investigators
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Ming-Shiang Wu, MD, PhD
Role: STUDY_DIRECTOR
National Taiwan University Hospital
Locations
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Chiayi Christian Hospital
Chiayi City, , Taiwan
National Taiwan University Hospital, Hsinchu Branch
Hsinchu, , Taiwan
E-DA University Hospital
Kaohsiung City, , Taiwan
Jyh-Ming Liou
Taipei, , Taiwan
Taipei Veteran General Hospital
Taipei, , Taiwan
Mackay Memorial Hospital, Taitung branch
Taitung, , Taiwan
National Taiwan University Hospital, Yun-Lin Branch
Yunlin County, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Po-Yuei Chen
Role: primary
Wen-Feng Hsu
Role: primary
Chi-Yang Chang, MD
Role: primary
Jing-Chuang Luo
Role: primary
Ming-Chung Bair
Role: primary
Yu-Ren Fang, MD
Role: primary
References
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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.
Other Identifiers
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201506129MINC
Identifier Type: -
Identifier Source: org_study_id
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