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Treating Primary Sclerosing Cholangitis and Biliary Atresia With Vancomycin

NCT ID: NCT02137668

Last Updated: 2016-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2028-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Primary Sclerosing Cholangitis Biliary Atresia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Oral Vancomycin

Every participant with PSC or BA will received the same Arm of Oral Vancomycin

Group Type EXPERIMENTAL

Oral Vancomycin

Intervention Type DRUG

Oral Vancomycin is given to PSC or BA participants

Interventions

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Oral Vancomycin

Oral Vancomycin is given to PSC or BA participants

Intervention Type DRUG

Other Intervention Names

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ANI

Eligibility Criteria

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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.
Minimum Eligible Age

2 Weeks

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sacramento Pediatric Gastroenterology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yinka Davies, M.D.

Role: PRINCIPAL_INVESTIGATOR

Sacramento Pediatric Gastroenterology

Locations

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Sacramento Pediatric Gastroenterology

Sacramento, California, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Yinka Davies, MD

Role: primary

Other Identifiers

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Davies 1

Identifier Type: -

Identifier Source: org_study_id