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

Information source: Stanford University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Primary Sclerosing Cholangitis

Intervention: Oral Vancomycin (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Stanford University

Official(s) and/or principal investigator(s):
Kenneth Cox, MD, Principal Investigator, Affiliation: Stanford University

Summary

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

Clinical Details

Official title: Treatment of Primary Sclerosing Cholangitis in Inflammatory Bowel Disease Patients With Oral Vancomycin by the Study of Its Antimicrobial and Immunomodulating Effects

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Determine the benefit of oral vancomycin therapy for Primary Sclerosing Cholangitis within 3 months of therapy.

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

Minimum age: 1 Year. Maximum age: N/A. Gender(s): Both.

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).

Locations and Contacts

Stanford University Medical Center, Palo Alto, California 94304, United States
Additional Information

Stanford Clinical Trials

Starting date: January 2012
Last updated: April 16, 2015

Page last updated: August 23, 2015

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