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

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ClinicalTrials.gov Identifier: NCT01802073
Recruitment Status : Completed
First Posted : March 1, 2013
Results First Posted : September 21, 2018
Last Update Posted : September 21, 2018
Sponsor:
Information provided by (Responsible Party):
Kenneth L. Cox, Stanford University

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

Condition or disease Intervention/treatment Phase
Primary Sclerosing Cholangitis Drug: Oral Vancomycin Phase 3

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 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).


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date : January 2012
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Count of Participants With Elevated Alanine Aminotransferase (ALT) at Baseline and With Clinically Significant Improvement at Month 3 [ Time Frame: Baseline; Month 3 ]
    Clinically significant improvement was determined by investigator assessment per participant based on their medical history and disease stage. Elevated ALT was any value greater than the upper limit of the standard reference range used by patient's laboratory.

  2. Count of Participants With Elevated Gamma-glutamyltransferase (GGT) at Baseline and With Clinically Significant Improvement at Month 3 [ Time Frame: Baseline; Month 3 ]
    Clinically significant improvement was determined by investigator assessment per participant based on their medical history and disease stage. Elevated GGT was any value greater than the upper limit of the standard reference range used by patient's laboratory.

  3. Count of Participants With Elevated ALT and/or GGT at Baseline and With Clinically Significant Improvement at Month 3 [ Time Frame: Baseline; Month 3 ]
    Clinically significant improvement was determined by investigator assessment per participant based on their medical history and disease stage. Elevated ALT (and GGT) was any value greater than the upper limit of the standard reference range used by patient's laboratory.

  4. Count of Participants With Abnormal Magnetic Resonance Cholangiopancreatography (MRCP) Imaging at Baseline and With Clinically Significant Improvement at Year 1 [ Time Frame: Baseline; Year 1 ]
    Clinically significant improvement was determined by investigator assessment per participant based on their medical history and disease stage. MRCP imaging was abnormal if it included biliary beading, biliary strictures, dilated bile duct, and/or liver fibrosis.

  5. Count of Participants With Abnormal Liver Biopsies at Baseline and With Clinically Significant Improvement at Year 1 [ Time Frame: Baseline; Year 1 ]
    Clinically significant improvement was determined by investigator assessment per participant based on their medical history and disease stage. Liver pathology was considered abnormal if the biopsy was S1 or greater on the liver fibrosis staging scale (S0 no fibrosis, S1 mild fibrosis, S2 moderate fibrosis, S3 sever fibrosis, S4 cirrhosis).

  6. Count of Participants With Abnormal MRCP and/or Liver Biopsy at Baseline and With Clinically Significant Improvement at Year 1 [ Time Frame: Baseline; Year 1 ]
    Clinically significant improvement was determined by investigator assessment per participant based on their medical history and disease stage. MRCP imaging was abnormal if it included biliary beading, biliary strictures, dilated bile duct, and/or liver fibrosis. Liver pathology was considered abnormal if the biopsy was S1 or greater on the liver fibrosis staging scale (S0 no fibrosis, S1 mild fibrosis, S2 moderate fibrosis, S3 sever fibrosis, S4 cirrhosis).



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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01802073


Locations
United States, California
Stanford University Medical Center
Palo Alto, California, United States, 94304
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Kenneth Cox, MD Stanford University

Additional Information:
Publications of Results:
Responsible Party: Kenneth L. Cox, Principle Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT01802073     History of Changes
Other Study ID Numbers: 22591
First Posted: March 1, 2013    Key Record Dates
Results First Posted: September 21, 2018
Last Update Posted: September 21, 2018
Last Verified: August 2018

Keywords provided by Kenneth L. Cox, Stanford University:
Inflammation of the bile ducts
biliary scarring
obstruction

Additional relevant MeSH terms:
Cholangitis
Cholangitis, Sclerosing
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents