Comparison of Two Novel First-line Anti-Helicobacter Pylori Therapy
Status:
Completed
Trial end date:
2018-05-01
Target enrollment:
Participant gender:
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.