A Phase 4 interventional study of Lansoprazole and Bismuth Potassium Citrate in Helicobacter Pylori Treatment Failure, sponsored by Shanghai Jiao Tong University School of Medicine. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-03-01.
Sponsored by Shanghai Jiao Tong University School of Medicine · Phase 4, Interventional, and Treatment
No trial has examined the the efficacy of high dose amoxicillin based quadruple therapy as second-line treatment for Helicobacter pylori infection. The study aims to compare the effectiveness and safety of 14-day high dose amoxicillin-based quadruple regiment with classical quadruple regiment for rescue eradication of Helicobacter pylori.
Helicobacter pylori is the most successful human pathogen infecting an estimated 50% of the global population, and is associated with a spectrum of disease states, including chronic gastritis, duodenal and gastric ulcer, gastric adenocarcinoma, and gastric mucosa-associated lymphoid tissue lymphoma (MALToma).
Most Consensus Conferences and Clinical Guidelines recommend the prescription of a triple therapy including a proton pump inhibitor (PPI) and clarithromycin with either amoxicillin or metronidazole, as first-line treatment. However, the effectiveness of these triple-therapy regimens seems to have diminished over time, largely as a result of emerging resistance of the organism to clarithromycin. Avoiding problems due to antibiotic resistance has become an important issue when deciding a second-line rescue therapy for H. pylori infection
Bismuth-containing quadruple therapies have been used widely in second-line therapy of H. pylori infection, and are recommended by the Maastricht IV Consensus Conference report. Quadruple therapy can achieve a high rate of eradication success as a second-line treatment. A meta-analysis of quadruple therapy showed that metronidazole resistance had limited effect on the outcome when adequate dosages and durations are used. This meta-analysis also showed that compliance with quadruple therapy is high. Classical bismuth-based quadruple therapy consists of a PPI, bismuth, tetracycline and metronidazole. This regiment meets the proposed criteria for a second-line treatment: it does not contain the key antibiotic of the original regimen (clarithromycin), the treatment is not affected by clarithromycin resistance, metronidazole resistance in vitro does not affect the outcome of quadruple therapy significantly, compliance with the regimen is high and the regimen is effective in most parts of the world. But this regiment has high rate of side effects because of tetracycline.
Amoxicillin has low resistance rate as well as low percentage of side effects. The replacement of tetracycline by high dose amoxicillin in classical bismuth-containing quadruple therapy may be a better choice. Therefore, we will do a randomized trial to compare the eradication rate of 14-day high dose amoxicillin and metronidazole based bismuth-containing quadruple therapy with classical quadruple therapy for second-line Helicobacter pylori treatment.
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This study's enrollment of 312 is above the median of 120 across 4,201 interventional studies indexed under Infections.
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Exclusion Criteria:
High dose amoxicillin/metronidazole-based quadruple therapy for 14 days: Lansoprazole 30mg bid, Bismuth Potassium Citrate 220mg bid, Amoxicillin 1000mg tid, Metronidazole 400mg qid
Drug: Lansoprazole · Drug: Bismuth Potassium Citrate · Drug: Metronidazole · Drug: Amoxicillin
Classical quadruple therapy for 14 days: Lansoprazole 30mg bid, Bismuth Potassium Citrate 220mg bid, Tetracycline 500mg qid, Metronidazole 400mg qid
Drug: Lansoprazole · Drug: Bismuth Potassium Citrate · Drug: Metronidazole · Drug: Tetracycline
antisecretory drug of each quadruple therapy
Also known as: proton pump inhibitor
one component of each quadruple therapy
Also known as: Bismuth
antibiotic of each quadruple therapy
Also known as: antibiotic
antibiotic of high dose amoxicillin based quadruple therapy
Also known as: antibiotic
antibiotic of classical quadruple therapy
Also known as: antibiotic
Eradication rate of Helicobacter pylori
Access eradication rate of H. pylori by intention to treat (ITT) and per-protocol (PP) analysis in each treatment group
Time frame: 2 months
Frequency of side effects of each treatment
Score side effects as mild, moderate or severe according to their influence on daily activities
Time frame: 2 months
Minimal inhibitory concentrations (MIC) of antibiotics against each helicobacter pylori clinical isolate
Determine MIC of amoxicillin, tetracycline, and metronidazole by the twofold agar dilution method.
Time frame: 2 months
This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.
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Shanghai Jiao Tong University School of Medicine