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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Prof
Yashwant
Mahida
Yash.mahida@nottingham.ac.uk
Prof
Yashwant
Mahida
Yash.mahida@nottingham.ac.uk
Intestinal infectious diseases
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In the proposed feasibility studies, we aim to investigate the role of ursodeoxycholic acid in the prevention of recurrence of C. difficile infection. The elderly on antibiotics represent the most susceptible population for C. difficile infection, which remains a significant clinical problem. Patients on antibiotics (for example, for pneumonia) may develop C. difficile infection because the antibiotics also kill those bacteria in the intestine that normally provide protection against C. difficile. About 25-30% have recurrence of C. difficile infection because of lack of recovery of protective intestinal bacteria. Recent research has shown that the protective bacteria work by converting primary bile acids into secondary bile acids. Ursodeoxycholic acid is a secondary bile acid which has been used for many years for other indications. Our recent laboratory research has shown that ursodeoxycholic acid inhibits the growth of C. difficile at concentrations found in stool samples of those taking it. We now wish to determine whether taking ursodeoxycholic acid can prevent the recurrence of C. difficile infection. However, first we need to undertake pilot feasibility studies to determine whether ursodeoxycholic acid will be tolerated and acceptable to those patients who have recently been treated for C. difficile infection. Thirty patients who have recently been treated for C. difficile infection will be recruited to the study, which will involve taking gradually increasing doses of ursodeoxycholic acid for a period of 6 weeks and will be followed up for a further 6 weeks.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Type: Drug;
You can take part if:
You may not be able to take part if:
-Pregnant or breast-feeding. -Gall bladder inflammation. -Frequent episodes of biliary colic. -Occlusion of the common bile duct or cystic duct. -Radio-opaque calcified gallstones. -Impaired contractility of the gall bladder. -Active small intestinal inflammation. -Previous resection of distal small intestine. -Treatment with bile salt binding small intestine. -Currently on antibiotic treatment (for any indication). -Diarrhoea (from any cause) at study initiation. -Hypersensitivity to bile acids or any excipient of the formulation. -Life expectancy less than 6 months.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
The study is sponsored by NOTTINGHAM UNIVERSITY HOSPITALS NHS TRUST and funded by Nottingham University Hospitals Charity And Other Related Charities; NIHR Nottingham Biomedical Research Centre; .
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Read full details
for Trial ID: CPMS 43588
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