NCT02137668 Treating Primary Sclerosing Cholangitis and Biliary Atresia With Vancomycin
| NCT ID | NCT02137668 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Sacramento Pediatric Gastroenterology |
| Condition | Primary Sclerosing Cholangitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2010-07 |
| Primary Completion | 2018-05 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 200 participants in total. It began in 2010-07 with a primary completion date of 2018-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Yinka Davies, M.D.
PRINCIPAL INVESTIGATOR
Sacramento Pediatric Gastroenterology
Frequently Asked Questions
Who can join the NCT02137668 clinical trial?
This trial is open to participants of all sexes, aged 2 Weeks or older, up to 40 Years, studying Primary Sclerosing Cholangitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT02137668 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT02137668 currently recruiting?
Yes, NCT02137668 is actively recruiting participants. Visit ClinicalTrials.gov or contact Sacramento Pediatric Gastroenterology to inquire about joining.
Where is the NCT02137668 trial being conducted?
This trial is being conducted at Sacramento, United States.
Who is sponsoring the NCT02137668 clinical trial?
NCT02137668 is sponsored by Sacramento Pediatric Gastroenterology. The principal investigator is Yinka Davies, M.D. at Sacramento Pediatric Gastroenterology. The trial plans to enroll 200 participants.