Dyspepsia Clinical Trial
Official title:
Prospective, Randomized Controlled Trial Comparing Amoxicillin and Metronidazole Based Bismuth-containing Quadruple Therapy With Amoxicillin and Clarithromycin Based Quadruple Therapy for First-line Helicobacter Pylori Eradication
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.
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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