A ground-breaking study investigating a life-threatening and contagious gut infection has launched in the UK - with researchers recruiting the first patient in the world to test a new preventative therapy.
Clostridioides difficile, commonly known as C. difficile or “C. diff’”, is a bacterium that lives in the gut. When the balance of gut bacteria is disrupted - often after taking antibiotics - it can cause infection (CDI), leading to symptoms such as diarrhoea, stomach pain and fever. In severe cases, CDI can be life-threatening, particularly for older or vulnerable people.
Nearly 19,000 CDI cases were reported in England last year, with numbers rising annually. Around one in seven patients die within 30 days - equivalent to about 50 deaths a week. The bacteria spreads easily and can survive on surfaces for months or even years, sometimes forcing hospital wards to close during outbreaks.
Now a trial, industry-sponsored and supported by the National Institute for Health and Care Research (NIHR), is examining a non-antibiotic drug which is designed to prevent the recurrence of CDI.
Lisa Shipp, a former business analyst, was first diagnosed with C. diff three years ago and then a second time where she was re-admitted to the hospital in October 2025.
Treating Lisa’s C. diff has been complicated by a pre-existing heart condition, impacting her heart health. Lisa - who took part in a previous trial related to her heart condition - struggled to maintain a normal diet due to her symptoms, and experienced diarrhoea and vomiting after contracting the infection.
She said: “This research is vital because, currently, the preventative therapy options for this debilitating condition are so limited. A preventative therapy to stop recurrence can’t come quick enough.”
Study offers hope to C. Diff sufferers
CDI can usually be treated with antibiotics, but preventative therapy options are limited. Recurrent infections often require repeated courses of antibiotics, increasing the risk of resistance. As resistance develops, infections become harder, or impossible, to treat, leading to more severe illness, higher mortality, and potentially greater strain on the NHS.
Researchers believe that the preventative therapy drug could help prevent CDI from coming back and protect patients from recurrence. Researchers will set out to establish effectiveness and safety.
Dr. Effrossyni Gkrania-Klotsas, NIHR National Specialty Lead for Infection, is leading the trial at Cambridge University Hospitals (CUH) where she is an Infectious Diseases Consultant. She said:
“C. diff can cause severe illness and can be life-threatening, particularly for older and vulnerable patients. And in hospital settings it is especially difficult to control, as it spreads easily and can survive on surfaces for long periods, requiring intensive infection-prevention measures. For patients, infection can mean prolonged illness and longer hospital stays; for staff, it can mean ward closures and disrupted care. So a non-antibiotic preventative approach could help protect patients while easing pressure on hospital services and improving overall patient safety.”
Researchers recruiting their first patient also demonstrates the success of the NIHR UK Vaccine Innovation Pathway (VIP). VIP works collaboratively with life science companies and health and care organisations to accelerate research. This gives patients faster access to cutting-edge therapies through research, while strengthening the UK’s competitiveness in life sciences.
The study’s first participant was recruited within 86 days, significantly faster than the government’s national ambition to reduce commercial trial setup times to under 150 days. Being the first country to recruit a patient into a global trial is an important performance measure for international commercial sponsors when evaluating where to place studies.
Dr. Maria Koufali, NIHR Life Sciences Industry Director, said: "This global-first achievement at Cambridge University Hospitals demonstrates what the UK can deliver when the entire research system works as one. Through the Vaccine Innovation Pathway, we have coordinated the expertise, infrastructure and delivery capability of the NHS and NIHR to open complex studies at unprecedented speed.
“In 2026 we will extend this national model across all commercial trials, giving industry a predictable, rapid route to patients and ensuring people in the UK access breakthrough therapies earlier.
“As NIHR marks its twentieth year, this is exactly the role we exist to play — turning scientific excellence into real-world impact, from prevention and early diagnosis to life-saving therapies and better care."
Dr. Effrossyni Gkrania-Klotsas added: “By bringing together the NIHR, the sponsor and delivery partners, CUH researchers showed how joined-up working across organisations can overcome complexity and deliver more than any one partner could alone. This work also supports the UK Government’s priority to shift from sickness to prevention, helping research reach patients faster and benefit more people.”
The research has been supported by NIHR Cambridge Clinical Research Facility, NIHR Cambridge Biomedical Research Centre and the NIHR Research Delivery Network.
