Treating Primary Sclerosing Cholangitis and Biliary Atresia With Vancomycin

NCT02137668 | Recruiting Phase 1

• 1 other identifier: Davies 1
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Sclerosing Cholangitis; Biliary Atresia

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Study Arms (1)

Oral Vancomycin

EXPERIMENTAL

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

Drug: Oral Vancomycin

Interventions

Oral Vancomycin DRUG

Oral Vancomycin is given to PSC or BA participants

Also known as: ANI

Oral Vancomycin

Eligibility Criteria

• Age: 2 Weeks - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sacramento Pediatric Gastroenterology: lead

Study Sites (1)

Sacramento Pediatric Gastroenterology

Sacramento, California, 95841, United States

RECRUITING

MeSH Terms

Conditions

Cholangitis, Sclerosing; Biliary Atresia

Interventions

Vancomycin

Condition Hierarchy (Ancestors)

Cholangitis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Digestive System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Yinka Davies, M.D.

  Sacramento Pediatric Gastroenterology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2014
• First Posted: May 14, 2014
• Study Start: July 1, 2010
• Primary Completion: May 1, 2018
• Study Completion (Estimated): July 1, 2028
• Last Updated: November 15, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)