| Summary: | Background: We previously reported that antofloxacin-based bismuth quadruple therapy was safe and effective for Helicobacter pylori ( H. pylori ) eradication. It is not clear whether the addition of Saccharomyces boulardii ( S. boulardii ) to antofloxacin-based quadruple therapy can improve the eradication rate of H. pylori and reduce adverse events. Objective: To investigate the effect of adding S. boulardii to antofloxacin-based quadruple therapy on the eradication rate of H. pylori and the adverse events. Design: Single-center, prospective randomized controlled study. Methods: A total of 172 patients with H. pylori infection were randomly assigned to the test and control groups. Patients in the control group ( n = 86) received antofloxacin-based bismuth quadruple therapy for 14 days. On this basis, cases in the test group ( n = 86) received S. boulardii 500 mg b.i.d. The eradication rate of H. pylori and adverse events were observed 4 weeks after the treatment. Results: There were no statistically significant differences in the eradication rates of H. pylori and frequency of diarrhea between the test group and control group ( p > 0.05). The duration of diarrhea in the test group was significantly shorter than in the control group ( p < 0.001). In addition, the two groups exhibited similar adverse event rates for epigastric pain, abdominal distention, dizzy, vomiting, and rash ( p > 0.05). The severity of adverse reactions was similar between the two groups ( p > 0.05), and most of them had mild adverse events. Conclusion: Although the addition of S. boulardii to antofloxacin-based quadruple therapy could not improve the eradication rate of H. pylori , it could shorten the time of antibiotic-associated diarrhea and reduce the incidence of diarrhea. Trial registration number: ChiCTR2200056931.
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