Primary Sclerosing Cholangitis With Oral Vancomycin by the Study of Its Antimicrobial and Immunomodulating Effects
This trial is active, not recruiting.
|Condition||primary sclerosing cholangitis|
|Start date||January 2012|
|End date||June 2017|
|Trial size||40 participants|
|Trial identifier||NCT01802073, 22591|
Determine the benefit of oral vancomycin therapy for Primary Sclerosing Cholangitis.
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
Determine the benefit of oral vancomycin therapy for Primary Sclerosing Cholangitis within 3 months of therapy.
time frame: Within 3 months of therapy
Male or female participants at least 1 year old.
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).
|Official title||Treatment of Primary Sclerosing Cholangitis in Inflammatory Bowel Disease Patients With Oral Vancomycin by the Study of Its Antimicrobial and Immunomodulating Effects|
|Principal investigator||Kenneth Cox, MD|
|Description||The purpose of this study is to evaluate changes in the fecal and salivary 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.|
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