This study assesses the effect of quadruple therapy for H. pylori, with the addition of probiotics Saccharomyces boulardii. In addition, he assesses whether this combination reduces the frequency of adverse effects of eradication therapy, and whether it affects the compliance.
Standard triple therapy for H. pylori infection proved to be insufficiently effective, primarily due to antibiotics resistance.Therefore, the latest Maastricht consensus suggests using bismuth-quadruple or non-bismuth-quadruple therapy, in regions with high clarithromycin resistance. The addition of probiotics with eradication therapy has never become a standard treatment. However, the Maastricht consensus suggest that the addition of probiotics could increase the effectiveness of quadruple therapy. The study was designed as a prospective, double-blind, randomized, case-control intervention study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
200
Rabeprazole 20 mg 2x1, for 14 days, followed by 1x1 for 14 days, Amoxicillin 1000 mg 2x1, for 14 days, Clarithromycin 500 mg 2x1, for 14 days, Metronidazole 500 mg 2x1, for 14 days, Saccharomyces boulardi 500 mg 1x1, for 3 week
Rabeprazole 20 mg 2x1, for 14 days, followed by 1x1 for 14 days, Amoxicillin 1000 mg 2x1, for 14 days, Clarithromycin 500 mg 2x1, for 14 days, Metronidazole 500 mg 2x1, for 14 days, Placebo 1x1, for 3 week
Result of urea breath test (Eradication of H.pylori)
Test remains positive (Eradication of H.pylori unsuccessful) or test becomes negative (eradication of H.pylori successful)
Time frame: baseline to 8 weeks after the introduction of the therapy
Side effects of eradication therapy
Number and severity of adverse events of standard eradication therapy
Time frame: baseline to 8 weeks after the introduction of the therapy
Compliance of eradication therapy
Patient successfully completed prescribed therapy
Time frame: baseline to 8 weeks after the introduction of the therapy
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