Status:
COMPLETED
Primary Sclerosing Cholangitis With Oral Vancomycin by the Study of Its Antimicrobial and Immunomodulating Effects
Lead Sponsor:
Stanford University
Conditions:
Primary Sclerosing Cholangitis
Eligibility:
All Genders
1+ years
Phase:
PHASE3
Brief Summary
Determine the benefit of oral vancomycin therapy for Primary Sclerosing Cholangitis.
Detailed Description
The purpose of this study is to evaluate changes in the fecal and salivary/urinary microbiota during vancomycin treatment of children and adults with Primary Sclerosing Cholangitis (PSC), identify fea...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT01802073
Start Date
January 1 2012
End Date
August 1 2015
Last Update
September 21 2018
Active Locations (1)
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1
Stanford University Medical Center
Palo Alto, California, United States, 94304