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Efficacy and Safety of Saccharomyces boulardii as Adjunct Therapy with Vancomycin in Treating Clostridioides difficile Infection: A Randomized Controlled Trial

Efficacy and Safety of Saccharomyces boulardii as Adjunct Therapy with Vancomycin in Treating Clostridioides difficile Infection: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20241202006
Enrollment
60
Registered
2024-12-02
Start date
2021-11-26
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients diagnosed with acute diarrhea associated with C. difficile infection (mild to moderate) require effective treatment. Clinical cure

Interventions

Two 250 mg of S. boulardii CNCM I-745 capsules were administered every 12 hours orally for 10 days, and 125 mg of vancomycin was taken orally every 6 hours for 10 days.,Two capsules of placebo were ad
Experimental Drug,Placebo Comparator Drug
S. boulardii, a non-pathogenic yeast,Placebo

Sponsors

Chiang Mai University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients were 20 years or older 2. Diagnosis of mild to moderate C. difficile infection, defined by the presence of nosocomial diarrhea (more than three unformed bowel movements in 24 hours) and detection of C. difficile, either toxin A or B, in a stool sample obtained within 48 hours before randomization.

Exclusion criteria

Exclusion criteria: 1. Severe C. difficile infection 2. Prior history of C. difficile infection 3. Presence of other known causes of diarrhea 4. History of chronic intestinal disease 5. History of abdominal surgery within the past three months 6. Severely immunocompromised state 7. Pregnancy

Design outcomes

Primary

MeasureTime frame
Clinical cure 56 days Rate of clinical cure

Secondary

MeasureTime frame
Recurrent Clostridium difficile infection 56 days Rate of recurrent infection,Global cure 56 days Rate of global cure,Diarrhea outcomes 56 days Duration of diarrhea, Total diarrheal day, Rate of diarrhea

Countries

Thailand

Contacts

Public ContactFaculty of Medicine Chinag Mai University

Chiang Mai University

medinfo@cmu.ac.th6653936150

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026