Recruiting
Phase 1

Vancomycin

Sponsor:

Sacramento Pediatric Gastroenterology

Code:

NCT02137668

Conditions

Primary Sclerosing Cholangitis

Biliary Atresia

Eligibility Criteria

Sex: All

Age: 0 - 40

Healthy Volunteers: Accepted

Interventions

Oral Vancomycin

Study Details

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

Study ID

NCT02137668

Start date

Jul, 2010

Status verified date

Nov, 2016

Completion date

Jul, 2028

Anticipated

Primary completion date

May, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 40

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

200 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Oral Vancomycin

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

Interventions

Oral Vancomycin

Oral Vancomycin is given to PSC or BA participants

Primary outcome measure

  • Determine the benefit of oral vancomycin therapy for Primary Sclerosing Cholangitis and Biliary Atresia [ Time Frame: 3 months ]

Central Contacts and Locations

Locations

Sacramento Pediatric Gastroenterology

Recruiting

Sacramento, California, United States, 95841

Contacts

Yinka Davies, MD

916-332-1244

Principal Investigator:

Yinka Davies, M.D.

More Information

Sponsor

Sacramento Pediatric Gastroenterology

Last update posted

Nov 15, 2016

Last verified

Nov, 2016

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sacramento Pediatric Gastroenterology on 2016-11-15.