Efficacy of Acetylcysteine-containing Triple Therapy in the First Line of Helicobacter Pylori Infection
Status:
Unknown status
Trial end date:
2016-10-01
Target enrollment:
Participant gender:
Summary
Helicobacter pylori infection has been shown to be associated with the development of gastric
cancer and peptic ulcer diseases. Eradication of H. pylori infection could reduce the
occurence or recurrence of these diseases. The triple treatment including a proton pump
inhibitor, clarithromycin, and amoxicillin or metronidazole to treat H pylori infection,
proposed at the first Maastricht conference has become universal since all the consensus
conferences and guidelines around the world recommended it. However, the eradication rate of
clarithromycin-based triple therapy has been declining in recent years, probably related to
the increasing resistant rate to clarithromycin. It was estimated that 15-20% of patients
would fail from first line standard eradication therapy and need second line rescue therapy.
The H. pylori persistence in human infections and its resistance to the drugs commonly used
in antimicrobial therapy have been attributed not only to genetic variability, but also to
ability of H. pylori to form biofilm as a strategy to overcome environmental stress and to
protect itself. Several recent reports indicate that H. pylori forms biofilm either in vitro
or in vivo, N-acetylcysteine (NAC) were thought to reduce and prevent biofilm formation. Two
small-scale clinical trials showed NAC offers additive effect on eradication effects of H.
pylori therapy. A recent trial showed N-acetylcysteine pre-treatment before a culture-guided
antibiotic regimen is effective in treating refractory H. pylori infection.
Aims: Therefore, we aim to assess
1. Whether triple therapy containing N-acetyl cysteine is more effective than standard
triple therapy
2. the impact of antibiotic resistance and cytochrome P450 C19(CYP2C19) polymorphism on the
eradication rate of triple therapy containing N-acetyl cysteine.