Feasibility studies to investigate the role of ursodeoxycholic acid in the prevention of recurrence of C. difficile infection (URSO)

8th May 2019 - ongoing

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Team: Professor Yash Mahida.

What is the purpose of the study?

The purpose of this study is to initiate clinical research that aims to determine the role of ursodeoxycholic acid, which is a bile acid supplement, in providing protection against recurrence of C. difficile infection.

C. difficile infection usually occurs when there is a reduction in the number of protective bacteria in the colon. Antibiotics that are required to treat an infection (for example pneumonia) in another part of the body, may also kill those bacteria in the large bowel that normally provide protection against C. difficile. Other antibiotics are used to treat C. difficile infection, which may further reduce the number of protective bacteria in the large bowel. Despite initial adequate treatment, about 25 - 30% of patients have recurrence of C. difficile infection, which is usually treated with more antibiotics. Some may suffer from numerous recurrences of C. difficile infection, which can be difficult to treat. Our aim is to determine the ability of a bile acid supplement (called ursodeoxycholic acid) to prevent recurrence of C. difficile infection. Recent research has shown that protective bacteria in the large bowel fight against C. difficile via bile acids that are similar to ursodeoxycholic acid. Moreover, our laboratory research has shown that ursodeoxycholic acid itself can fight against C. difficile. Ursodeoxycholic acid has been used for many years for the long-term treatment of some chronic liver conditions. Thus, knowledge of its safety profile is based on extensive clinical experience.

To determine whether taking ursodeoxycholic acid can prevent the recurrence of C. difficile infection a clinical trial that involves a large number of patients is required. Before embarking on such a trial, we need to carry out feasibility studies to determine whether ursodeoxycholic acid will be tolerated and acceptable to those patients who have recently had C. difficile infection. These studies will also enable us to obtain the views of patients regarding the practicality of the large definitive trial. For the feasibility studies, thirty patients who have recently been treated for C. difficile infection will be recruited. They will take gradually increasing doses of ursodeoxycholic acid for a period of 6 weeks and will be followed up for a further 6 weeks.

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