- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02541864
Comparison of Hybrid and Bismuth Quadruple Therapies for Helicobacter Pylori Eradication
October 20, 2017 updated by: Feng-Woei Tsay, Kaohsiung Veterans General Hospital.
Comparison of Hybrid and Bismuth Containing Quadruple Therapies for Helicobacter Pylori Eradication: a Randomized Controlled Trial
According the Maastricht IV consensus report publish in the Gut 2012, bismuth containing quadruple therapy was suggested to be the first choice for eradication therapy of Helicobacter pylori in the area with high clarithromycin resistance.
Whether hybrid therapy or 14-day bismuth containing quadruple therapy can replace standard triple therapy as the recommended first-line treatment is unknown.
The investigators compared the efficacy of 14-day hybrid therapy and 14-day bismuth containing quadruple therapy in first-line treatment.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
For this randomly assigned to receive either a 14-day hybrid therapy (a dual therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid for 7 days, followed by a quadruple therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid, clarithromycin 500 mg bid, and metronidazole 500 mg bid for a further 7 days) or a 14-day bismuth containing quadruple therapies (pantoprazole 40 mg bid , bismuth subcitrate 120 mg qid., tetracycline 500 mg qid, and metronidazole 250 mg qid for 14 days).at
a 1:1 ratio.
Our primary outcomes was the eradication rate by intention-to-treat and per- protocol analyses
Study Type
Interventional
Enrollment (Actual)
330
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Consecutive H pylori-infected outpatients, at least 20 years of age, with endoscopically proven peptic ulcer diseases or gastritis
Exclusion Criteria:
- previous H pylori-eradication therapy
- ingestion of antibiotics or bismuth within the prior 4 weeks
- patients with allergic history to the medications used
- patients with previous gastric surgery
- the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia)
- pregnant women
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Bismuth quadruple therapy
pantoprazole 40 mg bid for 14 days, bismuth subcitrate 120 mg qid for 14 days, tetracycline 500 mg qid for 14 days, metronidazole 250 mg qid for 14 days
|
pantoprazole 40 mg bid for 14 days, bismuth subcitrate 120 mg qid for 14 days, tetracycline 500 mg qid for 14 days, metronidazole 250 mg qid for 14 days
Other Names:
|
Active Comparator: Hybrid therapy
(pantoprazole 40 mg bid for 7 days, amoxicillin 1 g bid for 7 days) followed by (pantoprazole 40 mg bid for 7 days, amoxicillin 1 g bid for 7 days, clarithromycin 500 mg bid for 7 days, and metronidazole 500 mg bid for 7 days)
|
(pantoprazole 40 mg bid for 7 days, amoxicillin 1 g bid for 7 days) followed by (pantoprazole 40 mg bid for 7 days, amoxicillin 1 g bid for 7 days, clarithromycin 500 mg bid for 7 days, and metronidazole 500 mg bid for 7 days)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants in Which H. Pylori Was Eradicated
Time Frame: at the 6th week after the end of anti- H. pylori therapy
|
Repeated endoscopy with rapid urease test, histological examination and culture or urea breath tests are conducted to assess H. pylori status.
|
at the 6th week after the end of anti- H. pylori therapy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Malfertheiner P, Megraud F, O'Morain CA, Atherton J, Axon AT, Bazzoli F, Gensini GF, Gisbert JP, Graham DY, Rokkas T, El-Omar EM, Kuipers EJ; European Helicobacter Study Group. Management of Helicobacter pylori infection--the Maastricht IV/ Florence Consensus Report. Gut. 2012 May;61(5):646-64. doi: 10.1136/gutjnl-2012-302084.
- Vakil N, Megraud F. Eradication therapy for Helicobacter pylori. Gastroenterology. 2007 Sep;133(3):985-1001. doi: 10.1053/j.gastro.2007.07.008.
- Hunt RH, Lam SK. Helicobacter pylori: from art to a science. J Gastroenterol Hepatol. 1998 Jan;13(1):21-8. doi: 10.1111/j.1440-1746.1998.tb00540.x.
- Graham DY, Lew GM, Klein PD, Evans DG, Evans DJ Jr, Saeed ZA, Malaty HM. Effect of treatment of Helicobacter pylori infection on the long-term recurrence of gastric or duodenal ulcer. A randomized, controlled study. Ann Intern Med. 1992 May 1;116(9):705-8. doi: 10.7326/0003-4819-116-9-705.
- Sung JJ, Chung SC, Ling TK, Yung MY, Leung VK, Ng EK, Li MK, Cheng AF, Li AK. Antibacterial treatment of gastric ulcers associated with Helicobacter pylori. N Engl J Med. 1995 Jan 19;332(3):139-42. doi: 10.1056/NEJM199501193320302.
- Hsu PI, Lai KH, Tseng HH, Lo GH, Lo CC, Lin CK, Cheng JS, Chan HH, Ku MK, Peng NJ, Chien EJ, Chen W, Hsu PN. Eradication of Helicobacter pylori prevents ulcer development in patients with ulcer-like functional dyspepsia. Aliment Pharmacol Ther. 2001 Feb;15(2):195-201. doi: 10.1046/j.1365-2036.2001.00903.x.
- Satoh K. Does eradication of Helicobacter pylori reverse atrophic gastritis or intestinal metaplasia? Data from Japan. Gastroenterol Clin North Am. 2000 Dec;29(4):829-35. doi: 10.1016/s0889-8553(05)70150-3.
- Isaacson PG. Recent developments in our understanding of gastric lymphomas. Am J Surg Pathol. 1996;20 Suppl 1:S1-7. doi: 10.1097/00000478-199600001-00002.
- Wong BC, Lam SK, Wong WM, Chen JS, Zheng TT, Feng RE, Lai KC, Hu WH, Yuen ST, Leung SY, Fong DY, Ho J, Ching CK, Chen JS; China Gastric Cancer Study Group. Helicobacter pylori eradication to prevent gastric cancer in a high-risk region of China: a randomized controlled trial. JAMA. 2004 Jan 14;291(2):187-94. doi: 10.1001/jama.291.2.187.
- Malfertheiner P, Megraud F, O'Morain C, Bazzoli F, El-Omar E, Graham D, Hunt R, Rokkas T, Vakil N, Kuipers EJ. Current concepts in the management of Helicobacter pylori infection: the Maastricht III Consensus Report. Gut. 2007 Jun;56(6):772-81. doi: 10.1136/gut.2006.101634. Epub 2006 Dec 14.
- Hsu PI, Lai KH, Lin CK, Chen WC, Yu HC, Cheng JS, Tsay FW, Wu CJ, Lo CC, Tseng HH, Yamaoka Y, Chen JL, Lo GH. A prospective randomized trial of esomeprazole- versus pantoprazole-based triple therapy for Helicobacter pylori eradication. Am J Gastroenterol. 2005 Nov;100(11):2387-92. doi: 10.1111/j.1572-0241.2005.00264.x.
- Wu IC, Wu DC, Hsu PI, Lu CY, Yu FJ, Wang TE, Chang WH, Chen JJ, Kuo FC, Wu JY, Wang WM, Bair MJ. Rabeprazole- versus esomeprazole-based eradication regimens for H. pylori infection. Helicobacter. 2007 Dec;12(6):633-7. doi: 10.1111/j.1523-5378.2007.00553.x.
- Fock KM, Katelaris P, Sugano K, Ang TL, Hunt R, Talley NJ, Lam SK, Xiao SD, Tan HJ, Wu CY, Jung HC, Hoang BH, Kachintorn U, Goh KL, Chiba T, Rani AA; Second Asia-Pacific Conference. Second Asia-Pacific Consensus Guidelines for Helicobacter pylori infection. J Gastroenterol Hepatol. 2009 Oct;24(10):1587-600. doi: 10.1111/j.1440-1746.2009.05982.x.
- Graham DY, Fischbach L. Helicobacter pylori treatment in the era of increasing antibiotic resistance. Gut. 2010 Aug;59(8):1143-53. doi: 10.1136/gut.2009.192757. Epub 2010 Jun 4.
- Graham DY, Lu H, Yamaoka Y. Therapy for Helicobacter pylori infection can be improved: sequential therapy and beyond. Drugs. 2008;68(6):725-36. doi: 10.2165/00003495-200868060-00001.
- Gumurdulu Y, Serin E, Ozer B, Kayaselcuk F, Ozsahin K, Cosar AM, Gursoy M, Gur G, Yilmaz U, Boyacioglu S. Low eradication rate of Helicobacter pylori with triple 7-14 days and quadriple therapy in Turkey. World J Gastroenterol. 2004 Mar 1;10(5):668-71. doi: 10.3748/wjg.v10.i5.668.
- Bigard MA, Delchier JC, Riachi G, Thibault P, Barthelemy P. One-week triple therapy using omeprazole, amoxycillin and clarithromycin for the eradication of Helicobacter pylori in patients with non-ulcer dyspepsia: influence of dosage of omeprazole and clarithromycin. Aliment Pharmacol Ther. 1998 Apr;12(4):383-8. doi: 10.1046/j.1365-2036.1998.00315.x.
- Graham DY, Shiotani A. New concepts of resistance in the treatment of Helicobacter pylori infections. Nat Clin Pract Gastroenterol Hepatol. 2008 Jun;5(6):321-31. doi: 10.1038/ncpgasthep1138. Epub 2008 Apr 29.
- Chuah SK, Tsay FW, Hsu PI, Wu DC. A new look at anti-Helicobacter pylori therapy. World J Gastroenterol. 2011 Sep 21;17(35):3971-5. doi: 10.3748/wjg.v17.i35.3971.
- Zullo A, Vaira D, Vakil N, Hassan C, Gatta L, Ricci C, De Francesco V, Menegatti M, Tampieri A, Perna F, Rinaldi V, Perri F, Papadia C, Fornari F, Pilati S, Mete LS, Merla A, Poti R, Marinone G, Savioli A, Campo SM, Faleo D, Ierardi E, Miglioli M, Morini S. High eradication rates of Helicobacter pylori with a new sequential treatment. Aliment Pharmacol Ther. 2003 Mar 1;17(5):719-26. doi: 10.1046/j.1365-2036.2003.01461.x. Erratum In: Aliment Pharmacol Ther. 2003 May 1;17(9):1205.
- Vaira D, Zullo A, Vakil N, Gatta L, Ricci C, Perna F, Hassan C, Bernabucci V, Tampieri A, Morini S. Sequential therapy versus standard triple-drug therapy for Helicobacter pylori eradication: a randomized trial. Ann Intern Med. 2007 Apr 17;146(8):556-63. doi: 10.7326/0003-4819-146-8-200704170-00006.
- Gatta L, Vakil N, Leandro G, Di Mario F, Vaira D. Sequential therapy or triple therapy for Helicobacter pylori infection: systematic review and meta-analysis of randomized controlled trials in adults and children. Am J Gastroenterol. 2009 Dec;104(12):3069-79; quiz 1080. doi: 10.1038/ajg.2009.555. Epub 2009 Oct 20.
- Sanchez-Delgado J, Calvet X, Bujanda L, Gisbert JP, Tito L, Castro M. Ten-day sequential treatment for Helicobacter pylori eradication in clinical practice. Am J Gastroenterol. 2008 Sep;103(9):2220-3. doi: 10.1111/j.1572-0241.2008.01924.x. Epub 2008 Jun 28.
- Tsay FW, Tseng HH, Hsu PI, Wang KM, Lee CC, Chang SN, Wang HM, Yu HC, Chen WC, Peng NJ, Lai KH, Wu DC. Sequential therapy achieves a higher eradication rate than standard triple therapy in Taiwan. J Gastroenterol Hepatol. 2012 Mar;27(3):498-503. doi: 10.1111/j.1440-1746.2011.06885.x.
- Choi WH, Park DI, Oh SJ, Baek YH, Hong CH, Hong EJ, Song MJ, Park SK, Park JH, Kim HJ, Cho YK, Sohn CI, Jeon WK, Kim BI. [Effectiveness of 10 day-sequential therapy for Helicobacter pylori eradication in Korea]. Korean J Gastroenterol. 2008 May;51(5):280-4. Korean.
- Wu DC, Hsu PI, Wu JY, Opekun AR, Kuo CH, Wu IC, Wang SS, Chen A, Hung WC, Graham DY. Sequential and concomitant therapy with four drugs is equally effective for eradication of H pylori infection. Clin Gastroenterol Hepatol. 2010 Jan;8(1):36-41.e1. doi: 10.1016/j.cgh.2009.09.030. Epub 2009 Oct 3.
- Greenberg ER, Anderson GL, Morgan DR, Torres J, Chey WD, Bravo LE, Dominguez RL, Ferreccio C, Herrero R, Lazcano-Ponce EC, Meza-Montenegro MM, Pena R, Pena EM, Salazar-Martinez E, Correa P, Martinez ME, Valdivieso M, Goodman GE, Crowley JJ, Baker LH. 14-day triple, 5-day concomitant, and 10-day sequential therapies for Helicobacter pylori infection in seven Latin American sites: a randomised trial. Lancet. 2011 Aug 6;378(9790):507-14. doi: 10.1016/S0140-6736(11)60825-8. Epub 2011 Jul 21.
- Hsu PI, Wu DC, Wu JY, Graham DY. Modified sequential Helicobacter pylori therapy: proton pump inhibitor and amoxicillin for 14 days with clarithromycin and metronidazole added as a quadruple (hybrid) therapy for the final 7 days. Helicobacter. 2011 Apr;16(2):139-45. doi: 10.1111/j.1523-5378.2011.00828.x.
- Hsu PI, Lai KH, Wu CJ, Tseng HH, Tsay FW, Peng NJ, Chen TA, Chuah SK, Lin WS, Lo GH. High-dose versus low-dose esomeprazole-based triple therapy for Helicobacter pylori infection. Eur J Clin Invest. 2007 Sep;37(9):724-30. doi: 10.1111/j.1365-2362.2007.01852.x.
- Hsu PI, Lai KH, Tseng HH, Liu YC, Yen MY, Lin CK, Lo GH, Huang RL, Huang JS, Cheng JS, Huang WK, Ger LP, Chen W, Hsu PN. Correlation of serum immunoglobulin G Helicobacter pylori antibody titers with histologic and endoscopic findings in patients with dyspepsia. J Clin Gastroenterol. 1997 Dec;25(4):587-91. doi: 10.1097/00004836-199712000-00007.
- Dixon MF, Genta RM, Yardley JH, Correa P. Classification and grading of gastritis. The updated Sydney System. International Workshop on the Histopathology of Gastritis, Houston 1994. Am J Surg Pathol. 1996 Oct;20(10):1161-81. doi: 10.1097/00000478-199610000-00001.
- Hsu PI, Wu DC, Wu JY, Graham DY. Is there a benefit to extending the duration of Helicobacter pylori sequential therapy to 14 days? Helicobacter. 2011 Apr;16(2):146-52. doi: 10.1111/j.1523-5378.2011.00829.x.
- Peng NJ, Lai KH, Liu RS, Lee SC, Tsay DG, Lo CC, Tseng HH, Huang WK, Lo GH, Hsu PI. Clinical significance of oral urease in diagnosis of Helicobacter pylori infection by [13C]urea breath test. Dig Dis Sci. 2001 Aug;46(8):1772-8. doi: 10.1023/a:1010626225949.
- Tsay FW, Wu DC, Yu HC, Kao SS, Lin KH, Cheng JS, Wang HM, Chen WC, Sun WC, Tsai KW, Hsu PI. A Randomized Controlled Trial Shows that both 14-Day Hybrid and Bismuth Quadruple Therapies Cure Most Patients with Helicobacter pylori Infection in Populations with Moderate Antibiotic Resistance. Antimicrob Agents Chemother. 2017 Oct 24;61(11):e00140-17. doi: 10.1128/AAC.00140-17. Print 2017 Nov.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2013
Primary Completion (Actual)
August 1, 2015
Study Completion (Actual)
August 1, 2015
Study Registration Dates
First Submitted
August 31, 2015
First Submitted That Met QC Criteria
September 1, 2015
First Posted (Estimate)
September 4, 2015
Study Record Updates
Last Update Posted (Actual)
November 24, 2017
Last Update Submitted That Met QC Criteria
October 20, 2017
Last Verified
September 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Gastrointestinal Agents
- Anti-Bacterial Agents
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- Protein Synthesis Inhibitors
- Antiprotozoal Agents
- Antiparasitic Agents
- Anti-Ulcer Agents
- Proton Pump Inhibitors
- Antacids
- Metronidazole
- Amoxicillin
- Clarithromycin
- Bismuth
- Pantoprazole
- Tetracycline
- Bismuth tripotassium dicitrate
Other Study ID Numbers
- VGHKS12-CT11-08
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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