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

2025-06-02
Scientific reports 15(1)
- Taned Chitapanarux
- Umaporn Wiracha
- Poramed Winichakoon
- Parichat Salee
- Patrinee Traisathit

PubMed: 40457042
DOI: 10.1038/s41598-025-04986-2

Study Design

Type: Randomized Controlled Trial (RCT)
Population: 120 CDI patients diagnosed with positive stool toxin test
Methods: 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
Blinding: Double-blind
Duration: 10 days
Funding: Unclear

Rigorous Journal

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.

Research Insights

saccharomyces boulardii→Achieved Clinical Cure
Clinical cure rates were similar between groups (98.4% vs. 98.3%)
Effect
Neutral
Effect size
Small
Dose
two capsules of 250 mg every 12 h (1000 mg/day)
saccharomyces boulardii→Achieved Global Cure
significantly higher global cure rate (96.6% vs. 85.3%, p = 0.044)
Effect
Beneficial
Effect size
Small
Dose
two capsules of 250 mg every 12 h (1000 mg/day)
saccharomyces boulardii→Improved Clinical Cure Rate
Clinical cure rates were similar between groups (98.4% vs. 98.3%)
Effect
Neutral
Effect size
Small
Dose
1000 mg/day
saccharomyces boulardii→Improved Diarrhea
No significant differences were found in diarrheal outcomes
Effect
Neutral
Effect size
Small
Dose
two capsules of 250 mg every 12 h (1000 mg/day)
saccharomyces boulardii→Improved Functional Ability
No significant differences were found in ... functional ability
Effect
Neutral
Effect size
Small
Dose
two capsules of 250 mg every 12 h (1000 mg/day)
saccharomyces boulardii→Improved Global Cure Rate
the combination group had a significantly higher global cure rate (96.6% vs. 85.3%, p = 0.044)
Effect
Beneficial
Effect size
Small
Dose
1000 mg/day
saccharomyces boulardii→Improved Gut Microbiome
No significant differences were found in diarrheal outcomes
Effect
Neutral
Effect size
Small
Dose
1000 mg/day
saccharomyces boulardii→Reduced CDI Recurrence
lower recurrence rate (1.7% vs. 13.1%, p = 0.032)
Effect
Beneficial
Effect size
Large
Dose
two capsules of 250 mg every 12 h (1000 mg/day)
saccharomyces boulardii→Reduced Recurrence Rate
lower recurrence rate (1.7% vs. 13.1%, p = 0.032)
Effect
Beneficial
Effect size
Large
Dose
1000 mg/day

Adverse Events Reported

saccharomyces boulardii→adverse events
No significant differences were found in diarrheal outcomes, functional ability, or adverse events.
Finding
No significant difference
Significant
No
saccharomyces boulardii→adverse events (overall)
No significant differences were found in diarrheal outcomes, functional ability, or adverse events.
Finding
No significant difference
Magnitude
No significant differences were found in ... adverse events.
Significant
No
saccharomyces boulardii→Overall tolerability
No patients discontinued treatment due to intolerance.
Finding
Reported
saccharomyces boulardii→treatment discontinuation due to intolerance
No patients discontinued treatment due to intolerance.
Finding
Reported