Phase 3
N=34
Primary Sclerosing Cholangitis With Oral Vancomycin by the Study of Its Antimicrobial and Immunomodulating Effects
Primary Sclerosing Cholangitis
Bottom Line
View on ClinicalTrials.gov: NCT01802073 ↗Enrolled (actual)
34
Serious AEs
2.9%
Results posted
Sep 2018
Primary outcome: Primary: Count of Participants With Elevated Alanine Aminotransferase (ALT) at Baseline and With Clinically Significant Improvement at Month 3 — 10; 6 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Oral Vancomycin (Drug)
- Age
- Pediatric, Adult, Older Adult · 1+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Count of Participants With Elevated Alanine Aminotransferase (ALT) at Baseline and With Clinically Significant Improvement at Month 3 |
10; 6 | — |
| PRIMARY Count of Participants With Elevated Gamma-glutamyltransferase (GGT) at Baseline and With Clinically Significant Improvement at Month 3 |
8; 6 | — |
| PRIMARY Count of Participants With Elevated ALT and/or GGT at Baseline and With Clinically Significant Improvement at Month 3 |
10; 8 | — |
| PRIMARY Count of Participants With Abnormal Magnetic Resonance Cholangiopancreatography (MRCP) Imaging at Baseline and With Clinically Significant Improvement at Year 1 |
6; 4 | — |
| PRIMARY Count of Participants With Abnormal Liver Biopsies at Baseline and With Clinically Significant Improvement at Year 1 |
3; 0 | — |
| PRIMARY Count of Participants With Abnormal MRCP and/or Liver Biopsy at Baseline and With Clinically Significant Improvement at Year 1 |
10; 4 | — |
Summary
Determine the benefit of oral vancomycin therapy for Primary Sclerosing Cholangitis.
Eligibility Criteria
Inclusion Criteria
- PSC Diagnosis: Liver biopsy and/or imaging (MRCP, ERCP, CT, or US
- Colonoscopy within 1 year or starting of study
- 2 groups:
- IBD (Inflammatory bowel disease) and PSC: details of extent and type of IBD
- No IBD and PSC, but positive p-ANCA or ASCA serologies indicating possible IBD.
Exclusion Criteria
- Allergy to Vancomycin
- PSC not associated with IBD or NO positive IBD antibodies (p-ANCA [anti- neutrophil cytoplasmic antibody] or ASCA [anti-Saccharomyces cerevisiae antibody])
- Cholangiocarcinoma
- On oral or topical (enemas or suppositories) corticosteroids,topical mesalamine, or biologics (infliximab, adalimumab, certolizumab).
Data sourced from ClinicalTrials.gov (NCT01802073). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.