Comparison of Two Novel First-line Anti-Helicobacter Pylori Therapy
Condition: Helicobacter Pylori Infection
Study type: Interventional

Summary: 
      The Asian-Pacific Consensus Report has recommended that proton pump inhibitor
      (PPI)-clarithromycin-amoxicillin or metronidazole treatment for 7 to14 days is the first
      choice treatment for H pylori infection. As a general rule for the treatment of other
      infectious diseases, clinicians should prescribe therapeutic regimens that have a
      per-protocol eradication rate ≥ 90% for anti-H pylori therapy. However, the eradication rate
      of the standard triple therapy has generally declined to unacceptable levels (i.e., 80% or
      less) recently. The reasons for this fall in efficacy with time may relate to the increasing
      incidence of clarithromycin-resistant strains of H. pylori. Clarithromycin resistance is the
      major cause of eradication failure for stand triple therapy. Standard triple therapies should
      be abandoned in the areas with clarithromycin resistance ≥ 20% because the per-protocol
      eradication rates of standard therapies are often less than 85% and the intention-to-treat
      eradication rates are usually less than 80%..7-10 day non-bismuth containing quadruple
      therapy (Concomitant therapy) had been successful in the presence of clarithromycin
      resistance. Another novel treatment with 14-day high dose PPI and amoxicilin dual therapy
      could also attained >90 eradication rate in some studies. This novel treatment is simple and
      involved only two drugs and the most important of all is that amoxicillin resistance is still
      0% in Taiwan . High dose PPI has been used in several studies for H. pylori eradication in
      order to increase the intra-gastric PH for optimal eradication So far, there is still unclear
      which one is the best first-line H. pylori eradication regimen with highest eradication rate
      and least adverse effects. We therefore design a randomized controlled trial to
      simultaneously assess the efficacy novel 14-day high dose dual therapy by comparing to the
      7-day non-bismuth containing quadruple therapy in Taiwan and to investigate the host and
      bacterial factors predicting the treatment outcomes of eradication therapies.
    

Detailed description: 
      The Asian-Pacific Consensus Report has recommended that proton pump inhibitor
      (PPI)-clarithromycin-amoxicillin or metronidazole treatment for 7 to14 days is the first
      choice treatment for H pylori infection. As a general rule for the treatment of other
      infectious diseases, clinicians should prescribe therapeutic regimens that have a
      per-protocol eradication rate ≥ 90% for anti-H pylori therapy. However, the eradication rate
      of the standard triple therapy has generally declined to unacceptable levels (i.e., 80% or
      less) recently.[3-9] The reasons for this fall in efficacy with time may relate to the
      increasing incidence of clarithromycin-resistant strains of H. pylori. The main reasons for
      eradication failure for H pylori infection include antibiotic resistance, poor compliance and
      rapid metabolism of PPI. Clarithromycin resistance is the major cause of eradication failure
      for stand triple therapy. The rate of clarithromycin-resistant strains ranged from 49%
      (Spain) to 1% (Netherland) worldwide. Standard triple therapies should be abandoned in the
      areas with clarithromycin resistance ≥ 20% because the per-protocol eradication rates of
      standard therapies are often less than 85% and the intention-to-treat eradication rates are
      usually less than 80%. 7-10 day non-bismuth containing quadruple therapy (Concomitant
      therapy) had been successful in the presence of clarithromycin resistance. Another novel
      treatment with 14-day high dose PPI and amoxicilin dual therapy could also attained >90
      eradication rate in some studies. This novel treatment is simple and involved only two drugs
      and the most important of all is that amoxicillin resistance is still 0% in Taiwan. High dose
      PPI has been used in several studies for H. pylori eradication in order to increase the
      intra-gastric PH for optimal eradication So far, there is still unclear which one is the best
      first-line H. pylori eradication regimen with highest eradication rate and least adverse
      effects. We therefore design a randomized controlled trial to simultaneously assess the
      efficacy novel 14-day high dose dual therapy by comparing to the 7-day non-bismuth containing
      quadruple therapy in Taiwan and to investigate the host and bacterial factors predicting the
      treatment outcomes of eradication therapies.
    

Intervention name(s): Nexium; Amolin; Klaricid; Flagyl
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Esomeprazole ( Nexium )40 mg tid daily for 14 days in the high dose dual therapyarm and 40 mg bid daily for 7 days in the non-bismuth quadruple therapy; Amoxicillin 750 mg qid daily for 14 days in the high dose dual therapy and amoxicillin 1 g bid daily for 7 days in the non-bismuth quadruple therapy; clarithromycin 500 mg bid daily for 7 days in the non-bismuth quadruple therapy; Metronidazole (Flagyl) 500 mg tid daily for 7 days in the non-bismuth quadruple therapy
Other intervention name(s): Esomeprazole; Amoxicillin; Clarithromycin; Metronidazole
Intervention MeSH terms: Amoxicillin; Metronidazole; Clarithromycin; Esomeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Helicobacter pylori eradication; High dose proton pump inhibitor; High dose Amoxicillin; Concomitant therapy