Treating Primary Sclerosing Cholangitis and Biliary Atresia With Vancomycin

Part of paid clinical trials in Sacramento, California.

Sponsor
Sacramento Pediatric Gastroenterology
Study ID
NCT02137668
Phase
PHASE1
Status
Recruiting
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Conditions

  • Biliary Atresia
  • Primary Sclerosing Cholangitis

Eligibility Criteria

Sex
ALL
Age
2 Weeks - 40 Years
Healthy Volunteers
Accepted

Interventions

  • Oral Vancomycin — DRUG
    Oral Vancomycin is given to PSC or BA participants

Study Details

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.

Key Dates

Start date
Jul 31, 2010
Status verified
Nov 2016
Primary completion
May 31, 2018
Completion
Jul 31, 2028

Study Design

Enrollment
200 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

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

Locations (1)

FacilityCityStateZIPSite coordinators
Sacramento Pediatric GastroenterologySacramentoCalifornia95841
Yinka Davies, MD
916-332-1244
Yinka Davies, M.D. (PRINCIPAL_INVESTIGATOR)

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