Overview

VITALITY is one of the first studies to be funded through our Rare Disease Clinical Trials Programme. Led by Professor Palak Trivedi at the University of Birmingham, the international Phase 2b/3 trial will compare two doses of oral vancomycin against a placebo in people with PSC-IBD to determine whether the treatment can improve liver health and reduce bowel inflammation.

If successful, VITALITY could generate the robust clinical evidence needed to support approval of a new treatment for this rare condition that currently has no medicines proven to slow or stop disease progression.

About VITALITY

Growing evidence suggests that changes in the gut microbiome may play an important role in the development and progression of PSC-IBD. The VITALITY trial builds on a Phase 2a study led by Professor Trivedi, which found that oral vancomycin was associated with remission of bowel inflammation and improvements in liver blood test results.

VITALITY uses an innovative multi-arm, multi-stage design. Participants will be randomly assigned to receive one of two doses of oral vancomycin or a placebo. Following an interim analysis, the dose demonstrating the greatest benefit will be selected for the next stage of the trial, where it will be compared with a placebo in a larger patient group.

By testing the treatment in a rigorous international trial, researchers hope to confirm these early findings and better understand the relationship between gut bacteria, liver disease and bowel inflammation. If successful, this widely available antibiotic could offer a much-needed treatment option for people living with PSC-IBD while demonstrating the potential of drug repurposing to accelerate the development of therapies for rare diseases.

Alongside our funding, the trial is receiving contributions from PSC Support, Children’s PSC Foundation and UHB Charities.

About PSC-IBD

Primary sclerosing cholangitis (PSC) is a rare, chronic liver disease affecting around 3,500 people in the UK. The condition causes inflammation and scarring of the bile ducts, which carry bile from the liver to the digestive system. Over time, this can lead to serious liver damage and liver failure.

Most people with PSC also have an associated form of inflammatory bowel disease (IBD), known as PSC-IBD. This form of IBD can be particularly difficult to treat and is associated with an increased likelihood of bowel surgery and a higher lifetime risk of bowel cancer compared with other forms of IBD.

There are currently no proven treatments that can stop PSC from progressing, and liver transplantation remains the only life-extending treatment available. New therapies are urgently needed to improve outcomes and quality of life for people living with both PSC and PSC-IBD.

About our Rare Disease Clinical Trials Programme 

Our Rare Disease Clinical Trials Programme supports international clinical-stage projects that have the potential to bring new diagnostics, treatments and medical technologies closer to routine patient care.