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NCT Number: NCT02137668

Treating Primary Sclerosing Cholangitis and Biliary Atresia With Vancomycin

The purpose of this study is twofold. First, is to determine whether vancomycin is effective in the early treatment of Biliary Atresia (BA) and Primary Sclerosing Cholangitis (PSC), and if so, by what mechanism. Secondly, to characterize human intestinal microbial communities and their interactions with the host.

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Key information

Age range

2 week–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Sacramento Pediatric Gastroenterology

Sacramento, California, 95841, United States

Location status: Recruiting

Location contact

Yinka Davies, M.D.

PRINCIPAL_INVESTIGATOR

Yinka Davies, MD

CONTACT

916-332-1244

About this study

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. Investigation 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. In addition, changes in the metabolites of the blood will be analyzed.

To see if the antibiotic vancomycin, when used for the early treatment of Biliary Atresia (BA) and Primary Sclerosing Cholangitis (PSC) is effective treatment for these diseases. 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Persons who have primary sclerosing cholangitis, biliary atresia, a chronic intestinal disorder or who are undergoing upper or lower endoscopy.
  • Persons who have primary sclerosing cholangitis or biliary atresia who are good candidates for vancomycin therapy.

Exclusion criteria

  • Patients that have taken antibiotics and/or immunomodulators within the last 3 months will be excluded as this will alter the original bacterial flora.
  • Females who are pregnant may not participate.

Treatment and study plan

Oral Vancomycin

Drug

Oral Vancomycin is given to PSC or BA participants

Other names: ANI

Primary outcomes

  1. Determine the benefit of oral vancomycin therapy for Primary Sclerosing Cholangitis and Biliary Atresia

    Time frame: 3 months

    Blood tests, imaging studies and/or liver biopsy changes before and while on oral vancomycin will determine the benefit of the treatment.

Sponsors and collaborators

Lead sponsor

Sacramento Pediatric Gastroenterology

Other

Registry information

Official study title

The Human Gastrointestinal Tract Microbiota in the Setting of Treating Primary Sclerosing Cholangitis and Biliary Atresia With Vancomycin

Important dates

Study start
2010
Primary completion
2018
Study completion
2028
First posted
May 14, 2014
Registry last updated
Nov 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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