|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Mayo Clinic |
|---|---|
| Collaborator: |
PSC Partners Seeking a Cure Foundation |
| Information provided by: | Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT01085760 |
Purpose
The purpose of this study is to determine whether Vancomycin or Metronidazole is safe and beneficial in the treatment of Primary Sclerosing Cholangitis.
| Condition | Intervention | Phase |
|---|---|---|
|
Primary Sclerosing Cholangitis |
Drug: Vancomycin Drug: Metronidazole |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Pilot Study of Vancomycin or Metronidazole in Patients With Primary Sclerosing Cholangitis |
| Estimated Enrollment: | 40 |
| Study Start Date: | February 2010 |
| Estimated Study Completion Date: | February 2012 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Vancomycin 125 mg orally 4 times a day
The patients will be randomized into four groups of ten patients: one group will receive low dose vancomycin, one group will receive high dose vancomycin, one group will receive low dose metronidazole and one group will receive high dose metronidazole.
|
Drug: Vancomycin
Comparison of different doses of drug
Drug: Vancomycin
Comparison of dirrent drug doses
|
| Experimental: Vancomycin 250 mg orally 4 times a day |
Drug: Vancomycin
Comparison of different doses of drug
|
| Experimental: Metronidazole 250 mg orally 3 times a day |
Drug: Metronidazole
Comparison of different doses of drug
|
| Experimental: Metronidazole 500 mg orally 3 times a day |
Drug: Metronidazole
Comparison of different doses of drug
|
In this protocol, we propose the assessment of potential beneficial effects of the antibiotics vancomycin and metronidazole on liver biochemistries, liver related symptoms and Mayo risk score in patients with PSC. The patients will be randomized into four groups of ten patients: one group will receive low dose vancomycin, one group will receive high dose vancomycin, one group will receive low dose metronidazole and one group will receive high dose metronidazole. Each group will be treated for three months.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Jan L Petz, RN | 507-284-3565 | petz.janice@mayo.edu |
| Contact: Jill C Keach | 507-538-0678 | keach.jill@mayo.edu |
| United States, Minnesota | |
| Mayo Clinic | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Jan L Petz, RN Coordinator 507-284-3565 petz.janice@mayo.edu | |
| Contact: Jill C Keach, Study Coordinator 507-538-0678 keach.jill@mayo.edu | |
| Principal Investigator: Keith D Lindor, M.D. | |
| Principal Investigator: | Keith D Lindor, MD | Mayo Clinic |
More Information
| Responsible Party: | Dr. Keith Lindor, Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT01085760 History of Changes |
| Other Study ID Numbers: | 08-008247 |
| Study First Received: | March 10, 2010 |
| Last Updated: | May 6, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Cholangitis Cholangitis, Sclerosing Bile Duct Diseases Biliary Tract Diseases Digestive System Diseases Metronidazole Vancomycin Radiation-Sensitizing Agents |
Physiological Effects of Drugs Pharmacologic Actions Anti-Infective Agents Therapeutic Uses Antiprotozoal Agents Antiparasitic Agents Anti-Bacterial Agents |