NCT01085760

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

In this protocol, we propose the assessment of potential beneficial effects of the antibiotics vancomycin and metronidazole on liver biochemistries, liver related symptoms and Mayo risk score in patients with PSC. 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. Each group will be treated for three months.

Conditions

• Primary Sclerosing Cholangitis

Interventions

Type	Name	Description
DRUG	Vancomycin	Comparison of different doses of drug
DRUG	Vancomycin	Comparison of different doses of drug
DRUG	Metronidazole	Comparison of different doses of drug
DRUG	Metronidazole	Comparison of different doses of drug
DRUG	Vancomycin	Comparison of different drug doses

Timeline

• Start date: 2010-02-01
• Primary completion: 2011-11-01
• Completion: 2011-11-01
• First posted: 2010-03-12
• Last updated: 2013-09-19
• Results posted: 2013-09-19

Locations

1 site across 1 country: United States