Phase 3
Completed N=34
Primary Sclerosing Cholangitis With Oral Vancomycin by the Study of Its Antimicrobial and Immunomodulating Effects
Source: ClinicalTrials.gov NCT01802073 ↗Enrolled (actual)
34
Serious AEs
2.9%
Results posted
Sep 2018
Primary outcomePrimary: Count of Participants With Elevated Alanine Aminotransferase (ALT) at Baseline and With Clinically Significant Improvement at Month 3 — 10; 6 Participants
◆ Published Evidence
Highly cited
116citations · ~9 / year
Immunomodulatory effect of vancomycin on Treg in pediatric inflammatory bowel disease and primary sclerosing cholangitis.
Summary
Determine the benefit of oral vancomycin therapy for Primary Sclerosing Cholangitis.
Linked Publications (4)
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Immunomodulatory effect of vancomycin on Treg in pediatric inflammatory bowel disease and primary sclerosing cholangitis.
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Novel and emerging therapies for cholestatic liver diseases.
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Open-label prospective therapeutic clinical trials: oral vancomycin in children and adults with primary sclerosing cholangitis.
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Time for the dawn of multimodal therapies and the dusk for mono-therapeutic trials for cholestatic liver diseases?
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.