Phase 1
N=35
A Pilot Study of Vancomycin or Metronidazole in Patients With Primary Sclerosing Cholangitis
Primary Sclerosing Cholangitis
Bottom Line
View on ClinicalTrials.gov: NCT01085760 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Sep 2013
Primary outcome: Primary: Change From Baseline in Alkaline Phosphatase Following 12 Weeks of Treatment — -117; -49; -62; -36 U/L
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Vancomycin (Drug); Metronidazole (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Nov 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Alkaline Phosphatase Following 12 Weeks of Treatment |
-117; -49; -62; -36 | — |
| SECONDARY Change From Baseline in Total Bilirubin Following 12 Weeks Treatment |
-0.4; 0.05; -0.3; 0.05 | — |
| SECONDARY Change From Baseline in Mayo PSC Risk Score Following 12 Weeks of Treatment |
-0.65; -0.01; -0.26; -0.20 | — |
| SECONDARY Change From Baseline in C-Reactive Protein Following 12 Weeks of Treatment |
-2.2; 1; -3.6; 0 | — |
Summary
The purpose of this study is to determine whether Vancomycin or Metronidazole is safe and beneficial in the treatment of Primary Sclerosing Cholangitis.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01085760). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.