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Gastrointestinal Microbiota in Primary Sclerosing Cholangitis and Biliary Atresia With Vancomycin (PSC)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Stanford University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT01322386
First received: February 10, 2011
Last updated: March 23, 2011
Last verified: March 2011
History of Changes
  Purpose

The goals of the proposed work are two fold:

Firstly, to see if the antibiotic vancomycin may be used for the early treatment of Biliary Atresia (BA) and Primary Sclerosing Cholangitis (PSC). The investigators hope to learn what effect Vancomycin has on the bacteria that are present in stool, body fluid or intestinal tissue on someone who has BA and PSC and if so by what mechanism. Secondly, the investigators hope to learn to characterize human intestinal microbial communities (microbiome: the collection or collectivity of microorganisms) using molecular methods, examine the mechanisms of interaction between host and microbiome using genomic approaches, and determine how the microbiome both preserves local health and promotes pathology. The investigators will focus on primary sclerosing cholangitis, biliary atresia, as well as states of health. The composition of the associated microbiome will be assessed based on ribosomal DNA and RNA sequences, and attention will be given to richness (diversity), evenness (relative abundance), and variation with respect to time, person, and anatomic niche. Host response at the adjacent mucosal surface will be assessed based on genome-wide gene expression patterns.


Condition Intervention Phase
Primary Sclerosing Cholangitis
Biliary Atresia
 Drug: Vancomycin
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Human Gastrointestinal Tract Microbiota in the Setting of Treating Primary Sclerosing Cholangitis and Biliary Atresia With Vancomycin.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Determine the benefit of oral vancomycin therapy for Primary Sclerosing Cholangitis and Biliary Atresia [ Time Frame: Within 3 months of therapy ] [ Designated as safety issue: No ]
    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.


Enrollment: 21
Study Start Date: May 2007
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oral Vancomycin Drug: Vancomycin
Oral 50mg/Kg per day up to maximum of 1500 mg a day for three months.
Other Name: Vancocin

  Eligibility

Ages Eligible for Study:   1 Month to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of biliary atresia or primary sclerosing cholangitis.
  • Clinical controls who are undergoing upper endoscopy or colonoscopy and do not have biliary atresia or primary sclerosing cholangitis.
  • Subjects who have been on oral vancomycin for 1 year for biliary atresia or -

Exclusion Criteria:

  • Patients that have taken antibiotics within the last 3 month will be excluded as this will alter the original bacterial flora.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01322386

Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Kenneth L Cox, MD Stanford University
  More Information

Additional Information:
Long-term Treatment of Primary Sclerosing Cholangitis in Children With Oral Vancomycin: An Immunomodulating Antibiotic  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Kenneth Cox, MD, Stanford University
ClinicalTrials.gov Identifier: NCT01322386     History of Changes
Other Study ID Numbers: 4751
Study First Received: February 10, 2011
Last Updated: March 23, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Stanford University:
PSC
BA

Additional relevant MeSH terms:
Biliary Atresia
Cholangitis
Cholangitis, Sclerosing
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Digestive System Abnormalities
 Congenital Abnormalities
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013