A Pilot Study of Vancomycin or Metronidazole in Patients With Primary Sclerosing Cholangitis

NCT01085760 | Completed Phase 1 Results

• 1 other identifier: 08-008247
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether Vancomycin or Metronidazole is safe and beneficial in the treatment of Primary Sclerosing Cholangitis.

Conditions

Primary Sclerosing Cholangitis

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Alkaline Phosphatase Following 12 Weeks of Treatment

  baseline, 12 weeks

Secondary Outcomes (3)

• Change From Baseline in Total Bilirubin Following 12 Weeks Treatment

  baseline, 12 weeks

• Change From Baseline in Mayo PSC Risk Score Following 12 Weeks of Treatment

  baseline, 12 weeks

• Change From Baseline in C-Reactive Protein Following 12 Weeks of Treatment

  baseline, 12 weeks

Study Arms (4)

Vancomycin 125 mg orally 4 times a day

EXPERIMENTAL

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

Vancomycin 250 mg orally 4 times a day

EXPERIMENTAL

Drug: Vancomycin

Metronidazole 250 mg orally 3 times a day

EXPERIMENTAL

Drug: Metronidazole

Metronidazole 500 mg orally 3 times a day

EXPERIMENTAL

Drug: Metronidazole

Interventions

Vancomycin DRUG

Comparison of different doses of drug

Vancomycin 125 mg orally 4 times a day

Metronidazole DRUG

Comparison of different doses of drug

Metronidazole 250 mg orally 3 times a day

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Mayo Clinic: lead
• PSC Partners Seeking a Cure: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• Tabibian JH, Weeding E, Jorgensen RA, Petz JL, Keach JC, Talwalkar JA, Lindor KD. Randomised clinical trial: vancomycin or metronidazole in patients with primary sclerosing cholangitis - a pilot study. Aliment Pharmacol Ther. 2013 Mar;37(6):604-12. doi: 10.1111/apt.12232. Epub 2013 Feb 5.

  PMID: 23384404 DERIVED

MeSH Terms

Conditions

Cholangitis, Sclerosing

Interventions

Vancomycin; Metronidazole

Condition Hierarchy (Ancestors)

Cholangitis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Jayant A. Talwalkar
• Organization: Mayo Clinic

talwalkar.jayant@mayo.edu

507-538--4877

Study Officials

• Jayant A Talwalkar, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 10, 2010
• First Posted: March 12, 2010
• Study Start: February 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: September 19, 2013
• Results First Posted: September 19, 2013

Record last verified: 2013-07

Locations

US (1)