Vancomycin in Primary Sclerosing Cholangitis in Italy

Summary

Primary sclerosing cholangitis (PSC) is chronic fibroinflammatory disease of the liver. There is still no medical therapy proven to halt the progression of PSC or prevent its serious complications. This is a Phase 2 randomized, double bind, placebo-controlled, monocentric study evaluating the safety and efficacy of two doses of oral vancomycin (i.e. 750 mg and 1500 mg/day) in subject between 15 - 70 years old with PSC.

Timeline

Start

2023-06-15

Primary completion

2026-06

Completion

2026-06

Publications

• Cristoferi L, D'Amato D, Maino C, Bernasconi D, Dinelli ME, Malandrin SMI, Facciotti F, Vigano C, Pirola L, Festa MM, Gerussi A, Rossi E, Malinverno F, Tettamanti P, Cazzaniga ME, Corso R, Ippolito D, Galimberti S, Invernizzi P, Carbone M. Prospective, randomised, placebo-controlled, phase 2 clinical trial assessing the efficacy and safety of oral vancomycin in patients with primary sclerosing cholangitis with/out inflammatory bowel disease in Italy: study protocol of VanC-IT trial. BMJ Open. 2026 Jan 9;16(1):e106630. doi: 10.1136/bmjopen-2025-106630.

Drugs

Indications