ORAL AND GASTROINTESTINAL
Trial Name: "Follow-on" rifaximin for the prevention of relapse of clostridium-associated diarrhoea: a randomised trial (RAPID)
Chief Investigator: Robin Spiller, The University of Nottingham
Trial Description: Clostridium difficile infection is the main cause of antibiotic associated diarrhoea. It mainly affects frail and elderly hospitalised patients, although more recently a rising incidence of a more virulent strain has been associated with infection in younger patients and those in the community. It is characterised by a high incidence of recurrent infection, which can have deliberating consequences for already weakened patients. There are few well designed randomised trials in this condition, and treatment is largely based on experience and consensus opinion.
This trial is comparing rifaximin with placebo for people who have had successful treatment of clostridium dificile. Estimated sample size is 144 participants; with a recruitment target of 180 participants to allow for withdrawl. The primary outcome is relapse at 12 weeks. Recruitment is due to close in March 2016.
Contact: Robert Allen
Funding: NIHR Research for Patient Benefit
Status: Analysis and Reporting
Further Information: Robert Allen (Trial Coordinator) firstname.lastname@example.org
Trial Name: Systematic Evaluation of Aspirin and Fish Oil polyp prevention trial (seAfOod)
Chief Investigator: Mark Hull, University of Leeds
Trial Description: Colorectal cancer develops over a number of years from tumour initiation and benign adenoma (or polyp) growth, followed by transformation into malignant adenocarcinoma. Currently colorectal cancer prevention is aimed at detection and removal of asymptomatic colorectal polyps. Polyp removal does reduce bowel cancer risk, but does not prevent all cases of bowel cancer.
This factorial trial is assessing the effects of eicosapentaenoic acid (fish oil) and/or aspirin for people with colorectal polyps attending for colonoscopic surveillance in the NHS Bowel Cancer Screening Programme. Estimated sample size is 755 participants. The primary outcome is recurrent polyp/s at surveillance colonoscopy. Recruitment is due to close in June 2016.
Contact: Aisha Shafayat
Funding: NIHR Efficacy and Mechanism Evaluation
Publications: 2013-6; 2015-48
Further Information: Aisha Shafayat (Trial Manager) email@example.com