Post- Orthotopic Liver Transplantation, Primary Sclerosing Cholangitis
Conditions
Keywords
Vancomycin, Primary Sclerosing cholangitis, Post-liver transplantation
Brief summary
The purpose of the study is to investigate the safety and efficacy of oral vancomycin in patients with recurrent Primary Sclerosing Cholangitis (PSC) after liver transplantation. The primary endpoint is looking at the effect of the drug on liver function tests, an important surrogate of PSC disease activity at 12 weeks on treatment. Secondary endpoints include a decrease in liver function tests at 1 year, changes in bilirubin and adverse events. Effective treatment at the onset of PSC recurrence may lead to decreases in disease progression, recurrent liver failure, and repeat liver transplantation.
Interventions
DRUGVancomycin
Vancomycin belongs to the family of medicines called antibiotics.When taken by mouth, is used to treat Clostridium difficile-associated diarrhea (also called C diff). C diff is a type of bacteria that causes severe diarrhea. Oral Vancomycin is also used to treat enterocolitis caused by a certain bacteria (e.g., Staphylococcus aureus). Subjects enrolled in the study will take 500 mg capsule, 3 times per day for 3-12 weeks.
Sponsors
Ochsner Health System
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
The study will be conducted as a prospective open-label pilot study of up to 20 patients who will receive oral vancomycin for 3-12 months as treatment for recurrent PSC after liver transplantation. There will be no masking or randomization.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. History of prior orthotopic liver transplant or liver and kidney transplant. 2. Recurrent PSC confirmed by clinical labs (AST/ALT greater than 19 or ALKP greater than normal), imaging (MRCP or ERCP), and/or liver biopsy consistent with recurrent PSC. 3. No clinical evidence of liver transplant rejection and stability of post-transplant immune suppression dosing for three months prior to enrollment in the study 4. No changes to therapy for inflammatory bowel disease for at least three months prior to enrollment (for patients with history of IBD) 5. Patients on ursodiol must have been on a stable dose for two weeks prior to enrollment and dose must be stable for the remainder of the clinical trial. 6. All patients with inflammatory bowel disease must have had a colonoscopy within a year prior to enrollment 7. No antibiotics for 2 months before starting vancomycin 8. No probiotics for 1 month prior to starting vancomycin or during study period
Exclusion criteria
1. Allergy to vancomycin 2. Pre-existing advanced malignancies 3. Pregnancy or Lactation 4. Inability to provide consent 5. Findings suggestive of liver disease of other etiology such as chronic alcoholic liver disease, chronic hepatitis B or C infection, autoimmune hepatitis, primary biliary cirrhosis, hemochromatosis, Wilson's disease, or congenital biliary disease. 6. Current biliary obstruction 7. Active infection 8. Involvement in any other investigational study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Liver Function Test | 12 weeks | Alkaline Phosphatase (ALKP) +/- Alanine Transaminase (ALT) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Liver Function Test | 1 year | Alkaline Phosphatase (ALKP) +/- Alanine Transaminase (ALT) |
Countries
United States
Outcome results
None listed