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

Phase 1 Completed 35 enrolled Mayo Clinic PSC Partners Seeking a Cure · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

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

Timeline

Start: 2010-02
Primary completion: 2011-11
Completion: 2011-11

Outcome

Met primary endpoint

paper The primary endpoint was reached in the low-dose (-43% change in ALK, P = 0.03) and high-dose (-40%, P = 0.02) vancomycin groups PMID 23384404 ↗

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Metronidazole	Small molecule	250 mg	Oral
Subject	Metronidazole	Small molecule	500 mg	Oral
Subject	Vancomycin	Other / unclassified	125 mg	Oral
Subject	Vancomycin	Other / unclassified	250 mg	Oral