Personalized Treatment for Refractory H Pylori Infection

Helicobacter Pylori Infection Clinical Trial

Official title:

Personalized Treatment for Refractory H Pylori Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02547025
• Other study ID #: VGHKS13-CT12-17
• Status: Completed
• Phase: N/A
• Start date: August 1, 2012
• Est. completion date: October 31, 2021

Study information

• Verified date: October 2023
• Source: Kaohsiung Veterans General Hospital.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study, the investigators develop a personalized treatment according to culture-guided antibiotics plus high-dose proton-pump inhibitor and bismuth to treat refractory H pylori infection.

Description:

They are categorized into three groups: (1) patients who have positive result of culture with equal to or more than three susceptible antibiotics are treated by non-bismuth quadruple therapy (rabeprazole 20 mg q.d.s. and three effective antibiotics), (2) patients who have positive result of culture with one or two susceptible antibiotics are treated by bismuth-containing therapy (rabeprazole 20 mg q.d.s., bismuth subcitrate 120 mg q.d.s. and all the effective antibiotics), and (3) patients who have negative result of culture or whose culture data are unavailable will be treated by (rabeprazole 20 mg q.d.s, amoxicillin 500 mg q.d.s., tetracycline 500 mg q.d.s. and levofloxacin 500 mg o.d.) for 14 days.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: October 31, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

Inclusion Criteria:

H pylori-infected adult patients with at least two previous failed eradication attempts will be enrolled in this study after giving informed consent.

• positive results of both rapid urease test and histology,

• a positive result of Urea breath test,

• or a positive result of culture

Exclusion Criteria:

• ingestion of antibiotics, bismuth, or proton-pump inhibitor 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

• Communicable Diseases
• Helicobacter Pylori Infection
• Infections

Intervention

Drug:
• rabeprazole+3 antibiotics
(rabeprazole 20 mg q.d.s. and three effective antibiotics) for 14 days.
• rabeprazole+bismuth+2 antibiotics
(rabeprazole 20 mg q.d.s., bismuth subcitrate 120 mg q.d.s. and all the effective antibiotics) for 14 days.
• rabeprazole+amox+tetr+levo
(rabeprazole 20 mg q.d.s, amoxicillin 500 mg q.d.s., tetracycline 500 mg q.d.s. and levofloxacin 500 mg o.d.) for 14 days.

Locations

Country	Name	City	State
Taiwan	Kaohsiung Veterans General Hospital	Kaohsiung

Sponsors (2)

Lead Sponsor	Collaborator
Kaohsiung Veterans General Hospital.	Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (27)

Cammarota G, Martino A, Pirozzi G, Cianci R, Branca G, Nista EC, Cazzato A, Cannizzaro O, Miele L, Grieco A, Gasbarrini A, Gasbarrini G. High efficacy of 1-week doxycycline- and amoxicillin-based quadruple regimen in a culture-guided, third-line treatment approach for Helicobacter pylori infection. Aliment Pharmacol Ther. 2004 Apr 1;19(7):789-95. doi: 10.1111/j.1365-2036.2004.01910.x. — View Citation

Current European concepts in the management of Helicobacter pylori infection. The Maastricht Consensus Report. European Helicobacter Pylori Study Group. Gut. 1997 Jul;41(1):8-13. doi: 10.1136/gut.41.1.8. Erratum In: Gut 1997 Aug;41(2):276. — 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. doi: 10.7326/0003-4819-144-2-200601170-00006. — View Citation

Furuta T, Sugimoto M, Kodaira C, Nishino M, Yamade M, Uotani T, Ikuma M, Shirai N. The dual therapy with 4 times daily dosing of rabeprazole and amoxicillin as the 3rd rescue regimen for eradication of H. pylori. Hepatogastroenterology. 2010 Sep-Oct;57(102-103):1314-9. — View Citation

Gisbert JP. "Rescue" regimens after Helicobacter pylori treatment failure. World J Gastroenterol. 2008 Sep 21;14(35):5385-402. doi: 10.3748/wjg.14.5385. — View Citation

Goodwin CS, Marshall BJ, Blincow ED, Wilson DH, Blackbourn S, Phillips M. Prevention of nitroimidazole resistance in Campylobacter pylori by coadministration of colloidal bismuth subcitrate: clinical and in vitro studies. J Clin Pathol. 1988 Feb;41(2):207-10. doi: 10.1136/jcp.41.2.207. — View Citation

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. — View Citation

Hojo M, Miwa H, Nagahara A, Sato N. Pooled analysis on the efficacy of the second-line treatment regimens for Helicobacter pylori infection. Scand J Gastroenterol. 2001 Jul;36(7):690-700. doi: 10.1080/003655201300191941. — View Citation

Hsu PI, Lai KH, Chien EJ, Lin CK, Lo GH, Jou HS, Cheng JS, Chan HH, Hsu JH, Ger LP, Hsu PN, Tseng HH. Impact of bacterial eradication on the cell proliferation and p53 protein accumulation in Helicobacter pylori-associated gastritis. Anticancer Res. 2000 Mar-Apr;20(2B):1221-8. — 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. doi: 10.1097/00004836-199712000-00007. — 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. doi: 10.1046/j.1365-2036.2001.00903.x. — View Citation

Kita T, Sakaeda T, Aoyama N, Sakai T, Kawahara Y, Kasuga M, Okumura K. Optimal dose of omeprazole for CYP2C19 extensive metabolizers in anti-Helicobacter pylori therapy: pharmacokinetic considerations. Biol Pharm Bull. 2002 Jul;25(7):923-7. doi: 10.1248/bpb.25.923. — View Citation

Kuo CH, Hu HM, Kuo FC, Hsu PI, Chen A, Yu FJ, Tsai PY, Wu IC, Wang SW, Li CJ, Weng BC, Chang LL, Jan CM, Wang WM, Wu DC. Efficacy of levofloxacin-based rescue therapy for Helicobacter pylori infection after standard triple therapy: a randomized controlled trial. J Antimicrob Chemother. 2009 May;63(5):1017-24. doi: 10.1093/jac/dkp034. Epub 2009 Feb 26. — View Citation

Lee BH, Kim N, Hwang TJ, Lee SH, Park YS, Hwang JH, Kim JW, Jeong SH, Lee DH, Jung HC, Song IS. Bismuth-containing quadruple therapy as second-line treatment for Helicobacter pylori infection: effect of treatment duration and antibiotic resistance on the eradication rate in Korea. Helicobacter. 2010 Feb;15(1):38-45. doi: 10.1111/j.1523-5378.2009.00735.x. — View Citation

Luther J, Higgins PD, Schoenfeld PS, Moayyedi P, Vakil N, Chey WD. Empiric quadruple vs. triple therapy for primary treatment of Helicobacter pylori infection: Systematic review and meta-analysis of efficacy and tolerability. Am J Gastroenterol. 2010 Jan;105(1):65-73. doi: 10.1038/ajg.2009.508. Epub 2009 Sep 15. — 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

Megraud F, Lamouliatte H. Review article: the treatment of refractory Helicobacter pylori infection. Aliment Pharmacol Ther. 2003 Jun 1;17(11):1333-43. doi: 10.1046/j.1365-2036.2003.01592.x. — View Citation

Megraud F. Adjuvant therapy for Helicobacter pylori eradication: role of lansoprazole shown in vitro. J Clin Gastroenterol. 1995;20 Suppl 1:S24-7. — View Citation

Megraud F. H pylori antibiotic resistance: prevalence, importance, and advances in testing. Gut. 2004 Sep;53(9):1374-84. doi: 10.1136/gut.2003.022111. No abstract available. — View Citation

Padol S, Yuan Y, Thabane M, Padol IT, Hunt RH. The effect of CYP2C19 polymorphisms on H. pylori eradication rate in dual and triple first-line PPI therapies: a meta-analysis. Am J Gastroenterol. 2006 Jul;101(7):1467-75. doi: 10.1111/j.1572-0241.2006.00717.x. — 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. doi: 10.1023/a:1010626225949. — View Citation

Peng NJ, Lai KH, Liu RS, Lee SC, Tsay DG, Lo CC, Tseng HH, Huang WK, Lo GH, Hsu PI. Endoscopic 13C-urea breath test for the diagnosis of Helicobacter pylori infection. Dig Liver Dis. 2003 Feb;35(2):73-7. doi: 10.1016/s1590-8658(03)00014-8. — View Citation

Saad RJ, Schoenfeld P, Kim HM, Chey WD. Levofloxacin-based triple therapy versus bismuth-based quadruple therapy for persistent Helicobacter pylori infection: a meta-analysis. Am J Gastroenterol. 2006 Mar;101(3):488-96. doi: 10.1111/j.1572-0241.2006.00637.x. — View Citation

Savarino V, Zentilin P, Pivari M, Bisso G, Raffaella Mele M, Bilardi C, Borro P, Dulbecco P, Tessieri L, Mansi C, Borgonovo G, De Salvo L, Vigneri S. The impact of antibiotic resistance on the efficacy of three 7-day regimens against Helicobacter pylori. Aliment Pharmacol Ther. 2000 Jul;14(7):893-900. doi: 10.1046/j.1365-2036.2000.00780.x. — View Citation

Schwab M, Schaeffeler E, Klotz U, Treiber G. CYP2C19 polymorphism is a major predictor of treatment failure in white patients by use of lansoprazole-based quadruple therapy for eradication of Helicobacter pylori. Clin Pharmacol Ther. 2004 Sep;76(3):201-9. doi: 10.1016/j.clpt.2004.05.002. — View Citation

Wong WM, Gu Q, Chu KM, Yee YK, Fung FM, Tong TS, Chan AO, Lai KC, Chan CK, Wong BC. Lansoprazole, levofloxacin and amoxicillin triple therapy vs. quadruple therapy as second-line treatment of resistant Helicobacter pylori infection. Aliment Pharmacol Ther. 2006 Feb 1;23(3):421-7. doi: 10.1111/j.1365-2036.2006.02764.x. — View Citation

Wu DC, Hsu PI, Tseng HH, Tsay FW, Lai KH, Kuo CH, Wang SW, Chen A. Helicobacter pylori infection: a randomized, controlled study comparing 2 rescue therapies after failure of standard triple therapies. Medicine (Baltimore). 2011 May;90(3):180-185. doi: 10.1097/MD.0b013e31821c9d1c. — View Citation

* Note: There are 27 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	To assess eradication efficacy,repeated endoscopy with rapid urease test, histological examination and culture or Urea breath test.	eight weeks after the end of anti-H pylori therapy