Comparing the Efficacy of Reverse Hybrid Therapy and Bismuth Quadruple Therapy

Helicobacter Pylori Infection Clinical Trial

Official title:

Comparing the Efficacy and Impact on Gastrointestinal Microbiome of Reverse Hybrid Therapy and Bismuth Quadruple Therapy in Helicobacter Pylori Eradication

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02547038
• Other study ID #: VGHKS15-CT2-10
• Status: Completed
• Phase: N/A
• Start date: February 2015
• Est. completion date: October 2018

Study information

• Verified date: March 2019
• Source: Kaohsiung Veterans General Hospital.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Reverse hybrid therapy achieves a higher eradication rate than bismuth quadruple therapy remained unanswered.

Description:

A 14-day hybrid therapy invented by our study group appears very promising in H. pylori eradication, achieving excellent eradication rates of 99% and 97% according to per-protocol and intention-to-treat analyses, respectively. Recently, the investigators demonstrated that the eradication rate of reverse hybrid therapy was higher than that of standard triple therapy. However, whether reverse hybrid therapy achieves a higher eradication rate than bismuth quadruple therapy remained unanswered.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 352
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

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:
• pantoprazole+bismuth+tetra+metro
pantoprazole 40 mg twice daily, bismuth subcitrate 120 mg four times daily, and tetracycline 500 mg four times daily, and metronidazole 250 mg four times daily for 14 days
• (panto+amox+clar+metr)+(panto+amox)
a 7-day quadruple regimen with pantoprazole 40 mg twice daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 7-day dual regimen with pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily

Locations

Country	Name	City	State
Taiwan	Kaohsiung Veterans General Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Veterans General Hospital.

Country where clinical trial is conducted

Taiwan, 

References & Publications (31)

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De Francesco V, Margiotta M, Zullo A, Hassan C, Giorgio F, Burattini O, Stoppino G, Cea U, Pace A, Zotti M, Morini S, Panella C, Ierardi E. Prevalence of primary clarithromycin resistance in Helicobacter pylori strains over a 15 year period in Italy. J Antimicrob Chemother. 2007 Apr;59(4):783-5. Epub 2007 Feb 28. — View Citation

De Francesco V, Margiotta M, Zullo A, Hassan C, Troiani L, Burattini O, Stella F, Di Leo A, Russo F, Marangi S, Monno R, Stoppino V, Morini S, Panella C, Ierardi E. Clarithromycin-resistant genotypes and eradication of Helicobacter pylori. Ann Intern Med. 2006 Jan 17;144(2):94-100. — View Citation

Essa AS, Kramer JR, Graham DY, Treiber G. Meta-analysis: four-drug, three-antibiotic, non-bismuth-containing "concomitant therapy" versus triple therapy for Helicobacter pylori eradication. Helicobacter. 2009 Apr;14(2):109-18. doi: 10.1111/j.1523-5378.2009.00671.x. — View Citation

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. — View Citation

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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, Wu DC, Chen A, Peng NJ, Tseng HH, Tsay FW, Lo GH, Lu CY, Yu FJ, Lai KH. Quadruple rescue therapy for Helicobacter pylori infection after two treatment failures. Eur J Clin Invest. 2008 Jun;38(6):404-9. doi: 10.1111/j.1365-2362.2008.01951.x. Epub 2008 Apr 22. — View Citation

Hsu PI, Wu DC, Chen WC, Tseng HH, Yu HC, Wang HM, Kao SS, Lai KH, Chen A, Tsay FW. Randomized controlled trial comparing 7-day triple, 10-day sequential, and 7-day concomitant therapies for Helicobacter pylori infection. Antimicrob Agents Chemother. 2014 Oct;58(10):5936-42. doi: 10.1128/AAC.02922-14. Epub 2014 Jul 28. — 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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Malfertheiner P, Bazzoli F, Delchier JC, Celiñski K, Giguère M, Rivière M, Mégraud F; Pylera Study Group. Helicobacter pylori eradication with a capsule containing bismuth subcitrate potassium, metronidazole, and tetracycline given with omeprazole versus clarithromycin-based triple therapy: a randomised, open-label, non-inferiority, phase 3 trial. Lancet. 2011 Mar 12;377(9769):905-13. doi: 10.1016/S0140-6736(11)60020-2. Epub 2011 Feb 21. Erratum in: Lancet. 2011 Nov 19;378(9805):1778. Dosage error in article text. — View Citation

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. — View Citation

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Molina-Infante J, Romano M, Fernandez-Bermejo M, Federico A, Gravina AG, Pozzati L, Garcia-Abadia E, Vinagre-Rodriguez G, Martinez-Alcala C, Hernandez-Alonso M, Miranda A, Iovene MR, Pazos-Pacheco C, Gisbert JP. Optimized nonbismuth quadruple therapies cure most patients with Helicobacter pylori infection in populations with high rates of antibiotic resistance. Gastroenterology. 2013 Jul;145(1):121-128.e1. doi: 10.1053/j.gastro.2013.03.050. Epub 2013 Apr 3. — View Citation

Oh DH, Lee DH, Kang KK, Park YS, Shin CM, Kim N, Yoon H, Hwang JH, Jeoung SH, Kim JW, Jang ES, Jung HC. Efficacy of hybrid therapy as first-line regimen for Helicobacter pylori infection compared with sequential therapy. J Gastroenterol Hepatol. 2014 Jun;29(6):1171-6. — View Citation

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

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Sardarian H, Fakheri H, Hosseini V, Taghvaei T, Maleki I, Mokhtare M. Comparison of hybrid and sequential therapies for Helicobacter pylori eradication in Iran: a prospective randomized trial. Helicobacter. 2013 Apr;18(2):129-34. doi: 10.1111/hel.12017. Epub 2012 Nov 4. — View Citation

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Wang B, Wang YH, Lv ZF, Xiong HF, Wang H, Yang Y, Xie Y. Review: efficacy and safety of hybrid therapy for Helicobacter pylori infection: a systematic review and meta-analysis. Helicobacter. 2015 Apr;20(2):79-88. doi: 10.1111/hel.12180. Epub 2014 Nov 8. Review. — View Citation

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

Zullo A, De Francesco V, Hassan C, Morini S, Vaira D. The sequential therapy regimen for Helicobacter pylori eradication: a pooled-data analysis. Gut. 2007 Oct;56(10):1353-7. Epub 2007 Jun 12. Review. — View Citation

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* Note: There are 31 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	Evaluate eradication outcome by endoscopy urease test and histology or urea breath test (Number of Participants With Complete Eradication of Helicobacter Pylori)	sixth week after the end of anti- H. pylori therapy