What question did this study set out to answer?

This trial investigates whether Saccharomyces boulardii enhances H. pylori eradication rates and reduces adverse events during treatment.

April 25, 2026Open Access

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

Puntos clave

This trial investigates whether Saccharomyces boulardii enhances H. pylori eradication rates and reduces adverse events during treatment.
Single-center, prospective randomized controlled trial with 150 eligible patients.
Participants were divided into two groups: VA (vonoprazan and amoxicillin) and VAS (with Saccharomyces boulardii).
Treatment duration was 10 days, comparing eradication rates and adverse events.
Eradication rates: VA 89.3% vs. VAS 93.3% (P=0.384); per-protocol: VA 93.1% vs. VAS 94.6% (P=0.966).
Adverse events in VAS group were significantly lower at 5.3% compared to 21.3% in VA (P=0.004), particularly abdominal pain (P=0.020).
No significant differences in treatment compliance: VA 96.0% vs. VAS 98.7% (P=0.612).

Resumen

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. 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. 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. 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. 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/.

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