Amoxicillin/Metronidazole Based Quadruple Therapy for Helicobacter Pylori Eradication
Condition: Dyspepsia; Peptic Ulcer
MeSH terms: Peptic Ulcer; Dyspepsia
Study type: Interventional
Phase: Phase 4

Summary: 
      No trial has examined the the efficacy of amoxicillin and metronidazole based quadruple
      therapy for Helicobacter pylori treatment. The study aims to compare the effectiveness and
      safety of 14-day amoxicillin-/metronidazole-based quadruple regiment and classical quadruple
      regiment for Helicobacter pylori eradication.
    

Detailed description: 
      Helicobacter pylori is the most successful human pathogen infecting an estimated 50% of the
      global population. It is a common and potentially curable cause of dyspepsia and peptic ulcer
      disease. Eradication in patients with peptic ulcer or even functional or non-investigated
      dyspepsia is a cost effective approach.

      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. Due to the low efficacy achieved with these treatments, they
      have been deemed as unethical comparators in clinical trials. As antimicrobial resistance
      becomes more prevalent worldwide, treatment failure rates are likely to continue increasing,
      suggesting that new regimens for H pylori eradication must be sought.

      Bismuth-containing quadruple therapies have been used widely in H. pylori therapy with many
      permutations of doses and durations and with variable results. Classical bismuth-based
      quadruple therapy containing a PPI, bismuth, tetracycline and metronidazole has been
      recommended as the first-line treatment by the Maastricht IV Consensus Conference report and
      H. pylori Study Group of Chinese Society of Gastroenterology. But this regiment has high rate
      of side effects because of tetracycline. Standard triple therapy-based, bismuth-containing
      quadruple Therapy is also an alternative. Though addition bismuth and prolonging treatment
      duration can overcome H. pylori resistance to clarithromycin, its use as a first-line
      treatment is limited in areas of high clarithromycin resistance.

      Amoxicillin has low resistance rate as well as low percentage of side effects. The
      combination of amoxicillin and metronidazole in bismuth-containing quadruple therapy may be a
      better choice, which can avoid clarithromycin resistance and reduce side effects. Therefore,
      we will do a randomized trial to compare the eradication rate of 14-day amoxicillin and
      metronidazole based bismuth-containing quadruple therapy with amoxicillin and clarithromycin
      based quadruple therapy for Helicobacter pylori infection.
    

Intervention name(s): Lansoprazole; Bismuth Potassium Citrate; Amoxicillin; Metronidazole; Clarithromycin
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): antisecretory drug of each quadruple therapy; one component of each quadruple therapy; antibiotic of each quadruple therapy; antibiotic of the amoxicillin/metronidazole-based quadruple therapy; antibiotic of the amoxicillin/clarithromycin-based quadruple therapy
Other intervention name(s): proton pump inhibitor; Bismuth; antibiotic; antibiotic; antibiotic
Intervention MeSH terms: Anti-Bacterial Agents; Amoxicillin; Metronidazole; Clarithromycin; Antibiotics, Antitubercular; Potassium Citrate; Lansoprazole; Bismuth; Proton Pump Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: helicobacter pylori eradication; antibiotic