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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vancomycin group | Experimental | It is a single arm open label study and will constitute only one group that will be taking vancomycin for recurrent PSC post liver transplantation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vancomycin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Liver Function Test | Alkaline Phosphatase (ALKP) +/- Alanine Transaminase (ALT) | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Liver Function Test | Alkaline Phosphatase (ALKP) +/- Alanine Transaminase (ALT) | 1 year |
| Liver Function Test | Bilirubin | 1 year |
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Inclusion Criteria:
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ochsner Medical Center | New Orleans | Louisiana | 70121 | United States |
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| ID | Term |
|---|---|
| D015209 | Cholangitis, Sclerosing |
| ID | Term |
|---|---|
| D002761 | Cholangitis |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D014640 | Vancomycin |
| ID | Term |
|---|---|
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
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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.
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| D000602 |
| Amino Acids, Peptides, and Proteins |