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Background and aims <p>This randomized controlled trial (RCT) sought to investigate whether <i>Saccharomyces boulardii</i> (<i>S. boulardii</i>) can improve the <i>Helicobacter pylori</i> (<i>H. pylori</i>) eradication rate and reduce adverse events when added to the vonoprazan–amoxicillin dual therapy—a first-line treatment.</p> Methods <p>This is a single-center, prospective RCT. For the VA (vonoprazan 20&#xa0;mg twice daily, amoxicillin 750&#xa0;mg three times daily for 10 days) and VAS (vonoprazan 20&#xa0;mg twice daily, amoxicillin 750&#xa0;mg three times daily, and <i>S. boulardii</i> 250&#xa0;mg twice daily for 10 days) groups, 150 eligible patients were recruited between February 2024 and December 2024. The two groups were compared in terms of eradication rates, adverse events, safety, compliance, and eradication rate-related factors.</p> Results <p>The eradication rates of the VA and VAS therapies were 89.3% and 93.3% based on intention-to-treat analysis (<i>P</i> = 0.384) and 93.1% and 94.6% based on per-protocol analysis (<i>P</i> = 0.966), respectively. The incidence of adverse events was significantly lower in the VAS group (5.3%) than in the VA group (21.3%; <i>P</i> = 0.004), particularly with regard to abdominal pain (<i>P</i> = 0.020). There was no significant difference in compliance between the VA (96.0%) and VAS groups (98.7%, <i>P</i> = 0.612). Body surface area (BSA) was an influencing factor for the eradication rate in both groups. Liver and kidney functions in both groups before and after the therapy did not change significantly.</p> Conclusion <p>Adding <i>S. boulardii</i> to the VA-dual therapy may reduce the occurrence of adverse effects but may not improve the eradication rate. Low-BSA patients are more suitable candidates for this regimen.</p> Trial registration <p>The study protocol received approval and was subsequently registered at the Chinese Clinical Trial Registry (registration number: ChiCTR2300075347). The registration was completed on 1 September 2023, and the publicly accessible record can be found at <a href="https://www.chictr.org.cn/">https://www.chictr.org.cn/</a>.</p>

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Effects of supplementing with Saccharomyces boulardii on vonoprazan–amoxicillin dual therapy for naive Helicobacter pylori infection: a randomized controlled trial

  • 期刊论文

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  • 发表日期：

    2026年4月23日

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  • Zexuan Ji,
  • Dingni Qu,
  • Yonghao Feng,
  • Xiangrong Qin,
  • Xiaoyong Wang

摘要

Background and aims

This randomized controlled trial (RCT) sought to investigate whether Saccharomyces boulardii (S. boulardii) can improve the Helicobacter pylori (H. pylori) eradication rate and reduce adverse events when added to the vonoprazan–amoxicillin dual therapy—a first-line treatment.

Methods

This is a single-center, prospective RCT. For the VA (vonoprazan 20 mg twice daily, amoxicillin 750 mg three times daily for 10 days) and VAS (vonoprazan 20 mg twice daily, amoxicillin 750 mg three times daily, and S. boulardii 250 mg twice daily for 10 days) groups, 150 eligible patients were recruited between February 2024 and December 2024. The two groups were compared in terms of eradication rates, adverse events, safety, compliance, and eradication rate-related factors.

Results

The eradication rates of the VA and VAS therapies were 89.3% and 93.3% based on intention-to-treat analysis (P = 0.384) and 93.1% and 94.6% based on per-protocol analysis (P = 0.966), respectively. The incidence of adverse events was significantly lower in the VAS group (5.3%) than in the VA group (21.3%; P = 0.004), particularly with regard to abdominal pain (P = 0.020). There was no significant difference in compliance between the VA (96.0%) and VAS groups (98.7%, P = 0.612). Body surface area (BSA) was an influencing factor for the eradication rate in both groups. Liver and kidney functions in both groups before and after the therapy did not change significantly.

Conclusion

Adding S. boulardii to the VA-dual therapy may reduce the occurrence of adverse effects but may not improve the eradication rate. Low-BSA patients are more suitable candidates for this regimen.

Trial registration

The study protocol received approval and was subsequently registered at the Chinese Clinical Trial Registry (registration number: ChiCTR2300075347). The registration was completed on 1 September 2023, and the publicly accessible record can be found at https://www.chictr.org.cn/.