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Treating Primary Sclerosing Cholangitis and Biliary Atresia With Vancomycin

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ClinicalTrials.gov Identifier: NCT02137668
Recruitment Status : Recruiting
First Posted : May 14, 2014
Last Update Posted : November 15, 2016
Sponsor:
Information provided by (Responsible Party):
Sacramento Pediatric Gastroenterology

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.

Condition or disease Intervention/treatment Phase
Primary Sclerosing Cholangitis Biliary Atresia Drug: Oral Vancomycin Phase 1

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 2010
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : July 2028


Arm Intervention/treatment
Experimental: Oral Vancomycin
Every participant with PSC or BA will received the same Arm of Oral Vancomycin
Drug: Oral Vancomycin
Oral Vancomycin is given to PSC or BA participants
Other Name: ANI



Primary Outcome Measures :
  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.



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Ages Eligible for Study:   up to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02137668


Locations
United States, California
Sacramento Pediatric Gastroenterology Recruiting
Sacramento, California, United States, 95841
Contact: Yinka Davies, MD    916-332-1244      
Principal Investigator: Yinka Davies, M.D.         
Sponsors and Collaborators
Sacramento Pediatric Gastroenterology
Investigators
Principal Investigator: Yinka Davies, M.D. Sacramento Pediatric Gastroenterology

Responsible Party: Sacramento Pediatric Gastroenterology
ClinicalTrials.gov Identifier: NCT02137668     History of Changes
Other Study ID Numbers: Davies 1
First Posted: May 14, 2014    Key Record Dates
Last Update Posted: November 15, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data collected throughout study and will be shared via publications when available at certain time points.

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