Triple Therapy Versus Quadruple Therapies in the First Line Therapy of Helicobacter Pylori Infection
NCT ID: NCT01906879
Last Updated: 2017-06-12
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
1620 participants
INTERVENTIONAL
2013-06-30
2017-12-31
Brief Summary
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Therefore, we aim to compare the eradication rates and long term re-infection rates of quadruple therapy for 10 days versus non-bismuth quadruple therapy for 10 days vs. triple therapy for 14 days.
Methods: This will be a multi-center, open labeled, randomized control trial Patients: H. pylori infected patients who have willingness to receive eradication therapy
Testing for H. pylori infection Before First Line Ttreatment
(1)Any two positive of rapid urease test, histology, serology and culture or a positive UBT will be considered as H. pylori infected
After First Line Treatment: C13-Urea breath test will be used to assess the existence of H. pylori 6-8 weeks after first line therapy.
Long term reinfection: C13- Urea breath test will be used to assess the recurrence of H. pylori 1 year after eradication therapy
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Detailed Description
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Second line therapy: patients who fail from first line treatment will be rescue with the following treatment Group (A) Patient who fail from triple therapy will be retreated with bismuth quadruple therapy for 10 days D1-D10: lansoprazole 30mg bid + colloidal bismuth subcitrate 300mg tid + metronidazole 500mg tid + tetracycline 500mg tid Group (B) Patient who fail from non-bismuth quadruple therapy will be retreated with bismuth quadruple therapy for 10 days D1-D10: lansoprazole 30mg bid + colloidal bismuth subcitrate 300mg tid + metronidazole 500mg tid + tetracycline 500mg tid Group (C) Patients who fail from bismuth quadruple therapy will be retreated with non-bismuth quadruple therapy for 10 days D1-D10: lansoprazole 30mg bid + amoxicillin 1gm bid + clarithromycin 500mg bid + metronidazole 500mg bid
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Triple therapy (A)
lansoprazole, 30mg, twice daily, for 14 days, po clarithromycin, 500mg, twice daily, for 14 days, po amoxicillin, 1gm, twice daily, for 14 days, po
triple, quadruple, non-bismuth quadruple therapy
triple therapy, quadruple therapy, non-bismuth quadruple therapy
non-bismuth quadruple therapy
Group (B): non-bismuth quadruple therapy for 10 days: lansoprazole 30mg bid + amoxicillin 1gm bid + clarithromycin 500mg bid + metronidazole 500mg bid
triple, quadruple, non-bismuth quadruple therapy
triple therapy, quadruple therapy, non-bismuth quadruple therapy
bismuth quadruple therapy for 10 days
Group (C): bismuth quadruple therapy for 10 days D1-D10: lansoprazole 30mg bid + colloidal bismuth subcitrate 300mg tid + metronidazole 500mg tid + tetracycline 500mg tid
triple, quadruple, non-bismuth quadruple therapy
triple therapy, quadruple therapy, non-bismuth quadruple therapy
Interventions
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triple, quadruple, non-bismuth quadruple therapy
triple therapy, quadruple therapy, non-bismuth quadruple therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
20 Years
ALL
Yes
Sponsors
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National Taiwan University Hospital
OTHER
Responsible Party
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Principal Investigators
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Ming-Shiang Wu, MD. PhD
Role: PRINCIPAL_INVESTIGATOR
National Taiwan University Hospital, Taipei, Taiwan
Locations
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Chiayi Christian Hospital
Chiayi City, , Taiwan
National Taiwan University Hospital, Hsinchu Branch
Hsinchu, , Taiwan
E- DA Hospital and I-Shou University
Kaohsiung City, , Taiwan
Kaohsiung Medical University Hospital
Kaohsiung City, , Taiwan
Ming-Shiang Wu
Taipei, , Taiwan
Mackay Memorial Hospital, Taipei
Taipei, , Taiwan
Taipei Medical University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Mackay Memorial Hospital, Taitung
Taitung, , Taiwan
National Taiwan University Hospital, Yun-Lin Branch
Yun-Lin County, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Po-ye Chen
Role: primary
Wen Fong Hsu, MD
Role: primary
Chi-Yang Chang, MD
Role: primary
Jeng-Yih Wu
Role: primary
Jyh-Ming Liou, MD, PhD
Role: primary
Wen-Hsiung Chang, MD
Role: primary
Chun-Chao Chen
Role: primary
Jiing-Chyuan Luo, MD
Role: primary
Ming Chung Bair, MD
Role: primary
Chieh-Chang Chen, MD
Role: primary
References
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Liou JM, Chen CC, Chang CM, Fang YJ, Bair MJ, Chen PY, Chang CY, Hsu YC, Chen MJ, Chen CC, Lee JY, Yang TH, Luo JC, Chen CY, Hsu WF, Chen YN, Wu JY, Lin JT, Lu TP, Chuang EY, El-Omar EM, Wu MS; Taiwan Gastrointestinal Disease and Helicobacter Consortium. Long-term changes of gut microbiota, antibiotic resistance, and metabolic parameters after Helicobacter pylori eradication: a multicentre, open-label, randomised trial. Lancet Infect Dis. 2019 Oct;19(10):1109-1120. doi: 10.1016/S1473-3099(19)30272-5.
Liou JM, Fang YJ, Chen CC, Bair MJ, Chang CY, Lee YC, Chen MJ, Chen CC, Tseng CH, Hsu YC, Lee JY, Yang TH, Luo JC, Chang CC, Chen CY, Chen PY, Shun CT, Hsu WF, Hu WH, Chen YN, Sheu BS, Lin JT, Wu JY, El-Omar EM, Wu MS; Taiwan Gastrointestinal Disease and Helicobacter Consortium. Concomitant, bismuth quadruple, and 14-day triple therapy in the first-line treatment of Helicobacter pylori: a multicentre, open-label, randomised trial. Lancet. 2016 Nov 12;388(10058):2355-2365. doi: 10.1016/S0140-6736(16)31409-X. Epub 2016 Oct 18.
Other Identifiers
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201304017MINB
Identifier Type: -
Identifier Source: org_study_id
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