A Pilot Study of Vancomycin or Metronidazole in Patients With Primary Sclerosing Cholangitis
Completed · Phase 1
Conditions studied: Primary Sclerosing Cholangitis
In brief
The purpose of this study is to determine whether Vancomycin or Metronidazole is safe and beneficial in the treatment of Primary Sclerosing Cholangitis.
Key facts
- Study ID
- NCT01085760
- Run by
- Mayo Clinic
- People needed
- 35
- Starts
- 2010-02-01
- Expected to finish
- 2011-11-01
- Last updated by the study team
- 2013-09-19
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis of PSC established by alkaline phosphatase >1.5 times and/or two fold elevation of liver transaminases (AST and/or ALT) for at least 6 months duration.
- Cholangiography demonstrating intrahepatic and/or extrahepatic biliary obstruction, beading, or narrowing consistent with PSC.
- Both genders.
- Age ≥ 18 years old and < than 75 years old.
- Patient's informed consent for study participation.
You may not qualify if…
- Treatment with systematic antibiotics, azulfidine, ursodeoxycholic acid, corticosteroids, colchicine, methotrexate, azathioprine, cyclosporine, chlorambucil, budesonide, pentoxifylline, tacrolimus, silymarin or prednisone in the preceding three months.
- Active drug or alcohol use.
- Prior history of allergic reactions to the antibiotics which will be used in the study.
- Any condition that, in the opinion of the investigator, would interfere with the patients' ability to complete the study safely or successfully.
- Evidence of decompensated liver disease such as recurrent variceal bleeding, refractory ascites or spontaneous hepatic encephalopathy.
- Anticipated need for transplantation in one year (Mayo survival model <80% one-year survival without transplant).
- Findings highly suggestive of liver disease of other etiology such as chronic alcoholic liver disease, chronic hepatitis B or C infection, hemochromatosis, Wilson's disease, 1-antitrypsin deficiency, non-alcoholic steatohepatitis, primary biliary cirrhosis or secondary sclerosing cholangitis.
- Pregnancy or current lactation. Subjects becoming pregnant during the study will be withdrawn.
Where it is running
- Mayo Clinic — Rochester, Minnesota, United States
Full record on ClinicalTrials.gov
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