Primary Sclerosing Cholangitis With Oral Vancomycin by the Study of Its Antimicrobial and Immunomodulating Effects

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 features of the host microbiota that are associated with disease activity and/or
response to treatment and further delineate the immunological effects of oral vancomycin
treatment of PSC. This study will correlate changes in microbiota with the immunological
effects of oral vancomycin in children and adults with PSC. The results of this proposal will
lead to new and validated targets for diagnosis and treatment of PSC that will have high
impact in the short and long term for patients and their families.

Interim results were published in Abarbanel et al, J Clin Immunol 2013 (see References).

Inclusion Criteria:

- PSC Diagnosis: Liver biopsy and/or imaging (MRCP, ERCP, CT, or US

- Colonoscopy within 1 year or starting of study

- 2 groups:

1. IBD (Inflammatory bowel disease) and PSC: details of extent and type of IBD

2. 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).