BACKGROUND/AIMS: Recent studies have found that probiotics have anti-Helicobacter pylori (HP) properties. We evaluated the additive effects of (i) Saccharomyces boulardii combined with proton pump inhibitor (PPI)-based triple therapy and (ii) S. boulardii and a mucoprotective agent (DA-9601) coupled with PPI-based triple therapy for HP eradication. METHODS: We recruited 991 HP infected patients and randomized them into one of three groups, (A) PPI-based 7-day triple therapy, (B) the same triple therapy plus S. boulardii for 4 weeks, and (C) the same 7-day triple therapy plus S. boulardii and mucoprotective agent for 4 weeks. All patients in the three groups were tested via (13)C-urea breath test 4 weeks after the completion of the therapy. RESULTS: According to the results of an intention-to-treat analysis, HP eradication rates for the groups A, B, and C were 71.6% (237/331), 80.0% (264/330), and 82.1% (271/330), respectively (p = .003). According to the results of a per protocol analysis, the eradication rates were 80.0% (237/296), 85.4% (264/309) and, 84.9% (271/319), respectively (p = .144). The frequency of side effects in group B (48/330) and C (30/330) was lower than that in group A (63/331) (p < .05). CONCLUSION: This study suggests that supplementation with S. boulardii could be effective for improving HP eradication rates by reducing side effects thus helping completion of eradication therapy. However, there were no significant effects on HP eradication rates associated with the addition of mucoprotective agents to probiotics and triple therapy.
RCT Entities:
BACKGROUND/AIMS: Recent studies have found that probiotics have anti-Helicobacter pylori (HP) properties. We evaluated the additive effects of (i) Saccharomyces boulardii combined with proton pump inhibitor (PPI)-based triple therapy and (ii) S. boulardii and a mucoprotective agent (DA-9601) coupled with PPI-based triple therapy for HP eradication. METHODS: We recruited 991 HP infectedpatients and randomized them into one of three groups, (A) PPI-based 7-day triple therapy, (B) the same triple therapy plus S. boulardii for 4 weeks, and (C) the same 7-day triple therapy plus S. boulardii and mucoprotective agent for 4 weeks. All patients in the three groups were tested via (13)C-urea breath test 4 weeks after the completion of the therapy. RESULTS: According to the results of an intention-to-treat analysis, HP eradication rates for the groups A, B, and C were 71.6% (237/331), 80.0% (264/330), and 82.1% (271/330), respectively (p = .003). According to the results of a per protocol analysis, the eradication rates were 80.0% (237/296), 85.4% (264/309) and, 84.9% (271/319), respectively (p = .144). The frequency of side effects in group B (48/330) and C (30/330) was lower than that in group A (63/331) (p < .05). CONCLUSION: This study suggests that supplementation with S. boulardii could be effective for improving HP eradication rates by reducing side effects thus helping completion of eradication therapy. However, there were no significant effects on HP eradication rates associated with the addition of mucoprotective agents to probiotics and triple therapy.