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Treating Primary Sclerosing Cholangitis and Biliary Atresia With Vancomycin

Primary Purpose

Primary Sclerosing Cholangitis, Biliary Atresia

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Oral Vancomycin
Sponsored by
Sacramento Pediatric Gastroenterology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Sclerosing Cholangitis

Eligibility Criteria

2 Weeks - 40 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Sacramento Pediatric GastroenterologyRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Oral Vancomycin

Arm Description

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

Outcomes

Primary Outcome Measures

Determine the benefit of oral vancomycin therapy for Primary Sclerosing Cholangitis and Biliary Atresia
Blood tests, imaging studies and/or liver biopsy changes before and while on oral vancomycin will determine the benefit of the treatment.

Secondary Outcome Measures

Full Information

First Posted
May 12, 2014
Last Updated
November 10, 2016
Sponsor
Sacramento Pediatric Gastroenterology
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1. Study Identification

Unique Protocol Identification Number
NCT02137668
Brief Title
Treating Primary Sclerosing Cholangitis and Biliary Atresia With Vancomycin
Official Title
The Human Gastrointestinal Tract Microbiota in the Setting of Treating Primary Sclerosing Cholangitis and Biliary Atresia With Vancomycin
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Recruiting
Study Start Date
July 2010 (undefined)
Primary Completion Date
May 2018 (Anticipated)
Study Completion Date
July 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sacramento Pediatric Gastroenterology

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Sclerosing Cholangitis, Biliary Atresia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Oral Vancomycin
Arm Type
Experimental
Arm Description
Every participant with PSC or BA will received the same Arm of Oral Vancomycin
Intervention Type
Drug
Intervention Name(s)
Oral Vancomycin
Other Intervention Name(s)
ANI
Intervention Description
Oral Vancomycin is given to PSC or BA participants
Primary Outcome Measure Information:
Title
Determine the benefit of oral vancomycin therapy for Primary Sclerosing Cholangitis and Biliary Atresia
Description
Blood tests, imaging studies and/or liver biopsy changes before and while on oral vancomycin will determine the benefit of the treatment.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Weeks
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yinka Davies, M.D.
Organizational Affiliation
Sacramento Pediatric Gastroenterology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sacramento Pediatric Gastroenterology
City
Sacramento
State/Province
California
ZIP/Postal Code
95841
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yinka Davies, MD
Phone
916-332-1244
First Name & Middle Initial & Last Name & Degree
Yinka Davies, M.D.

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data collected throughout study and will be shared via publications when available at certain time points.

Learn more about this trial

Treating Primary Sclerosing Cholangitis and Biliary Atresia With Vancomycin

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