Treating Primary Sclerosing Cholangitis and Biliary Atresia With Vancomycin
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age2-40
SponsorSacramento Pediatric Gastroenterology
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Oral Vancomycin
DrugOral Vancomycin is given to PSC or BA participants
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Oral VancomycinExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
3 monthsSponsors and contacts
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Source ClinicalTrials.gov