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

Stanford University

Status and phase: Completed; Phase 3

Conditions: Primary Sclerosing Cholangitis

Treatments: Drug: Oral Vancomycin

Study type: Interventional

Funder types: Other

Identifiers

NCT01802073

22591

Details and patient eligibility

About

Determine the benefit of oral vancomycin therapy for Primary Sclerosing Cholangitis.

Full 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 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).

Enrollment: 34 patients

Sex: All

Ages: 1+ year old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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34 participants in 1 patient group

Oral Vancomycin

Experimental group

Description:

1) For children who weight \< or = 30 kg, the vancomycin dose will be 50 mg/kg/day given orally 3 times per day for the 1st month and continue with the same dose for subsequent months if the clinical laboratory studies improved and are normal. If the laboratory studies are not normal the dose will be increased to 75 mg/kg/day given orally 3 times per day for the 2nd month and 100mg/kg/day given orally 3 times per day the 3rd month. If the laboratory studies do not improve by the end of the 3rd month since starting the vancomycin, the vancomycin will be stopped and the child will not continue the study. 2) For adults and children who weigh \>30 kg, the vancomycin dose will be 500 mg given orally 3 times per day for the 1st month and continue with this dose if the clinical laboratory studies improve and are normal. If the laboratory studies are not normal the dose will be increased to 750 mg 3 times per day for the 2nd month and 1000 mg 3 times per day the 3rd month.

Treatment:

Drug: Oral Vancomycin