Comparison of Hybrid and Bismuth Quadruple Therapies for Helicobacter Pylori Eradication

Helicobacter Pylori Infection Clinical Trial

Official title:

Comparison of Hybrid and Bismuth Containing Quadruple Therapies for Helicobacter Pylori Eradication: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02541864
• Other study ID #: VGHKS12-CT11-08
• Status: Completed
• Phase: N/A
• First received: August 31, 2015
• Last updated: October 20, 2017
• Start date: July 2013
• Est. completion date: August 2015

Study information

• Verified date: September 2015
• Source: Kaohsiung Veterans General Hospital.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Helicobacter Infections
• Helicobacter Pylori Infection

Intervention

Drug:
• 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
• 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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Veterans General Hospital.

References & Publications (33)

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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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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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. — View Citation

Sánchez-Delgado J, Calvet X, Bujanda L, Gisbert JP, Titó 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. — View Citation

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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. — View Citation

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. — View Citation

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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. — View Citation

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. — View Citation

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, Papadìa C, Fornari F, Pilati S, Mete LS, Merla A, Potì 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. Erratum in: Aliment Pharmacol Ther. 2003 May 1;17(9):1205. — View Citation

* Note: There are 33 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants in Which H. Pylori Was Eradicated	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