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

This study is currently recruiting participants.
Verified February 2013 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01802073
First received: February 21, 2013
Last updated: February 27, 2013
Last verified: February 2013
  Purpose

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


Condition Intervention Phase
Primary Sclerosing Cholangitis
Drug: Oral Vancomycin
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Primary Sclerosing Cholangitis in Inflammatory Bowel Disease Patients With Oral Vancomycin by the Study of Its Antimicrobial and Immunomodulating Effects

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Determine the benefit of oral vancomycin therapy for Primary Sclerosing Cholangitis within 3 months of therapy. [ Time Frame: Within 3 months of therapy ] [ Designated as safety issue: No ]
    Determine the benefit of oral vancomycin therapy for Primary Sclerosing Cholangitis. Blood tests(liver enzymes - ALT and GGT), imaging studies (MRI, ERCP) and/or liver biopsy changes before and while on oral vancomycin will assess the benefit of the therapy.


Estimated Enrollment: 40
Study Start Date: January 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oral Vancomycin
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.
Drug: Oral Vancomycin
Other Name: Vancocin

Detailed 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.

  Eligibility

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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:

    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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01802073

Locations
United States, California
Stanford University Medical Center Recruiting
Palo Alto, California, United States, 94304
Contact: Ken Cox, MD    650-721-2250    KCox@LPCH.ORG   
Contact: Shamita Shah, MD    650-736-5555    shamita.shah@stanford.edu   
Principal Investigator: Ken Cox, MD         
Sub-Investigator: Shamita Shah, MD         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Kenneth Cox, MD Stanford University
  More Information

Additional Information:
No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01802073     History of Changes
Other Study ID Numbers: 22591
Study First Received: February 21, 2013
Last Updated: February 27, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Stanford University:
Inflammation of the bile ducts
biliary scarring
obstruction

Additional relevant MeSH terms:
Cholangitis
Cholangitis, Sclerosing
Inflammatory Bowel Diseases
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Intestinal Diseases
Anti-Infective Agents
Vancomycin
Therapeutic Uses
Pharmacologic Actions
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on April 17, 2014