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A clinical study comparing the efficacy and safety of Saccharomyces boulardii powder combined with vancomycin and metronidazole to monotherapy with antibiotics in the treatment of ulcerative colitis complicated by Clostridium difficile infection

A clinical study comparing the efficacy and safety of Saccharomyces boulardii powder combined with vancomycin and metronidazole to monotherapy with antibiotics in the treatment of ulcerative colitis complicated by Clostridium difficile infection

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500109901
Enrollment
Unknown
Registered
2025-09-26
Start date
2025-10-08
Completion date
Unknown
Last updated
2025-09-29

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

Conditions

Clostridium difficile infection

Interventions

Subgroup 1: Brachydia yeast powder (500mg bid) + vancomycin (125mg qid) ×14 days :None
Subgroup 2: Brachydia yeast powder (500mg bid) + metronidazole (500mg tid) ×14 days :None
Subgroup 3: Vancomycin (125mg qid) ×14 days alone :None
Subgroup 4: Metronidazole (500mg tid) ×14 days alone:None

Sponsors

Sun Yat-sen University Affiliated Sixth Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age between 18-75 years, both male and female, diagnosed with UC (refer to the 2023 Xi'an Guidelines for the Diagnosis and Treatment of Ulcerative Colitis in China); 2. CDI diagnosis: diarrhea (>=3 times/day) and positive for Clostridium difficile toxin B test; 3. Modified Mayo score of 3-12 points (mild to moderate active phase); 4. The treatment of Clostridium difficile infection is determined by the clinical physician's opinion; 5. The individual or legal guardian signs the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with tumor diseases and a survival period of less than 6 months; 2. Patients with fulminant colitis, intestinal perforation, or toxic megacolon; 3. Patients who have used probiotics or fecal microbiota transplantation within 30 days; 4. Individuals with combined immune deficiency (HIV, active tuberculosis), autoimmune diseases, or blood disorders, or those who have recently received immunosuppressive therapy; 5. Individuals with coagulation disorders or bleeding tendencies; 6. Pregnant or breastfeeding women; 7. Individuals with mental illness; 8. Those deemed unsuitable for inclusion by the researcher.

Design outcomes

Primary

MeasureTime frame
Clostridium difficile toxin B negativization rate;

Countries

China

Contacts

Public ContactGao Xiang

Sun Yat-sen University Affiliated Sixth Hospital

250124464@qq.com+86 135 0240 5878

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026