Efficacy and safety of Saccharomyces boulardii as adjunct therapy with Vancomycin in treating Clostridioides difficile infection: A randomized controlled trial

Chitapanarux et al., 2025 | Sci Rep | Rct

Citation

Chitapanarux Taned, Wiracha Umaporn, ... Traisathit Patrinee. Efficacy and safety of Saccharomyces boulardii as adjunct therapy with Vancomycin in treating Clostridioides difficile infection: A randomized controlled trial. Sci Rep. 2025-Jun-02;15(1):19326. doi:10.1038/s41598-025-04986-2

Abstract

Clostridioides difficile infection (CDI) is a significant cause of hospital-acquired diarrhea, leading to high morbidity, recurrence, and healthcare costs. Probiotics like Saccharomyces boulardii show potential as an adjunct therapy to standard CDI treatment, but further trials are needed to confirm their efficacy. This study assessed the efficacy and safety of S. boulardii combined with vancomycin for treating mild to moderate CDI. 120 CDI patients diagnosed with positive stool toxin test were randomly assigned to receive two capsules of 250 mg of S. boulardii or a placebo every 12 h alongside 125 mg of vancomycin every 6 h for 10 days. The primary endpoint was the clinical cure rate, with secondary endpoints including recurrence, global cure rate, and diarrheal outcomes. Clinical cure rates were similar between groups (98.4% vs. 98.3%), but the combination group had a significantly higher global cure rate (96.6% vs. 85.3%, p = 0.044) and lower recurrence rate (1.7% vs. 13.1%, p = 0.032). No significant differences were found in diarrheal outcomes, functional ability, or adverse events. No patients discontinued treatment due to intolerance. In conclusion, adding S. boulardii to vancomycin reduced CDI recurrence without affecting functional recovery or increasing adverse events.

Key Findings

boulardii to vancomycin reduced CDI recurrence without affecting functional recovery or increasing adverse events.

Outcomes Measured

  • Requires manual extraction

Population

Field Value
Population See abstract
Sample Size See abstract
Age Range See abstract
Condition See abstract

MeSH Terms

  • Humans
  • Vancomycin
  • Saccharomyces boulardii
  • Male
  • Clostridium Infections
  • Female
  • Middle Aged
  • Probiotics
  • Aged
  • Clostridioides difficile
  • Adult
  • Treatment Outcome
  • Anti-Bacterial Agents
  • Diarrhea

Evidence Classification

  • Level: Rct
  • Publication Types: Journal Article, Randomized Controlled Trial
  • Vertical: saccharomyces-boulardii-diarrhea

Provenance


Source extracted via PubMed E-utilities API on 2026-04-09