Clarithromycin, Amoxicillin, and Metronidazole Based Regimens to Treat Helicobacter Pylori Infections in Colombia
Status:
Completed
Trial end date:
2007-02-01
Target enrollment:
Participant gender:
Summary
More than half of the world's population is infected with Helicobacter pylori, a bacterium
that colonizes the human stomach. Although most infected subjects live free of symptoms and
disease outcomes (except superficial gastritis), only a few develop peptic ulcers or gastric
cancer, while some others may develop non-ulcer dyspepsia. Current clinical practice for the
management of peptic ulcer disease includes testing for and treating H. pylori, if present.
Although there are triple therapies that contain 2 antibiotics plus a bismuth compound, a
proton-pump inhibitor, or a H2-receptor antagonist which are effective at eliminating H.
pylori in Europe and North America, these treatments are dramatically less effective in
developing countries. Our recent meta-analysis showed quadruple therapies containing
clarithromycin, amoxicillin, metronidazole and a proton pump inhibitor to be effective in the
presence of clarithromycin or metronidazole resistance. However, this regimen has yet to be
tested in a developing country. Therefore, in the current randomized clinical trial in Pasto,
Colombia, we aim to examine the effectiveness of clarithromycin, amoxicillin, metronidazole
with and without a proton pump inhibitor compared to the Food and Drug Administration
approved 10-day regimen containing clarithromycin, amoxicillin and omeprazole. Since
antibiotic therapy is most effective within a specific gastric pH range, and since mutifocal
atrophy results in damage and loss of the acid producing parietal cells, we will test the
efficacy of our modified therapy stratified by diagnosis of multifocal atrophic gastritis.
Phase:
Phase 3
Details
Lead Sponsor:
University of North Texas Health Science Center
Collaborators:
Universidad del Valle, Colombia Vanderbilt University Vanderbilt University Medical Center