IASO trial of anakinra for acute severe ulcerative colitis
Despite huge progress in the outpatient management of ulcerative colitis, there are still around 2,500 admissions for acute severe UC in the UK every year. Our current standard initial therapy (intravenous corticosteroids) is based upon the landmark trial of Truelove and Witt in the 1950s; advances since have been restricted to rescue therapy for those failing this initial care. Led by Tim Raine and Arthur Kaser in Cambridge, with a team of researchers from across the UK, the IASO trial will be a multicentre, randomised, double-blind, placebo-controlled trial to test the hypothesis that IL-1 blockade using anakinra, a safe and affordable antagonist of the IL-1 receptor, can improve outcomes when given as initial therapy in acute severe UC alongside corticosteroids. Funding for IASO has been provided by the NIHR and MRC through the EME programme, with additional funding from the Wellcome Trust and Swedish Orphan Biovitrum, totalling in all in excess of £1.6m. IASO will set this major clinical trial in the context of a detailed scientific study of the largest cohort of patients with acute severe UC ever assembled. Patient recruitment will begin in 2017, with final trial reporting expected in 2021/22.
METRIC Study closed for recruitment - add-on study funded
The NIHR HTA funded Metric study (MR Enterography or ulTRasound In Crohn’s disease; “Diagnostic accuracy for the extent and activity of newly diagnosed and relapsed Crohn’s disease: a multicentre prospective comparison of magnetic resonance enterography and small bowel ultrasound compared to a reference standard in those aged 16 and over”) has closed to recruitment; data collection and analysis are underway. The research team led by Prof Stuart Taylor and Dr Andrew Plumb were successful in securing £358,183 funding from the HTA for an add on study (MRI enterography as a predictor of disabling disease in newly diagnosed Crohn's disease) to develop a prognostic model for future disabling disease in those newly diagnosed with Crohn's disease. In particular, the group will investigate whether findings on MR enterography at diagnosis are predictive of a worse long-term outcome, over and above existing prognostic markers. Co-investigators: Ailsa Hart, Andrew Plumb, Gauraang Bhatnagar, Nicola Muirhead, John Hamlin, Stuart Bloom, Susan Mallett, Ilan Jacobs, Susan Tebbs, Simon Travis, Stephen Morris, Steve Halligan.
Crohn's Disease trial funding success: cine MRI
Joint collaborations between members of the British Society of Gastrointestinal and Abdominal Radiology (BSGAR) and the BSG have led to recent grant success from the NIHR. Led by Prof Stuart Taylor and Dr Andrew Plumb, the team has been awarded £895,292 by NIHR EME to investigate “Small bowel motility quantified by cine MRI as a predictor of long term response in patients with Crohn's disease commencing biological therapy”. The trial will recruit from 10 centers and perform dynamic cine MRI imaging of the small bowel in those commencing biological therapies for active disease. Small bowel motility is reduced by active inflammation and this can be quantified using MRI and specialist analysis software. The study will test if early improvement in small bowel motility after commencing therapy is better predictive of 1 year response or remission than CRP or calprotectin. An embedded mechanistic study led by Dr Gordon Moran will explore the relationship between gut peptides, inflammatory cytokines, aberrant small bowel motility on MRI, and patient abdominal symptoms. A team led by Prof Ailsa Hart will investigate the effect of body composition on patient response. Co-investigators: Gordon Moran, Ailsa Hart, Alex Menys, Andrew Plumb, Stuart Bloom, Tariq Ahmad, Ilan Jacobs, Susan Tebbs, Caroline Dore, Simon Travis, Steve Halligan.
NIHR Study Support Service Route Map
Planning to deliver a study in the NHS? Take a look at the route map to see when and how support can be offered by the NIHR Study Support Service.
TRITON grant announcement
Professor Spiller and a team of experts from the Neurogastroenterology & Motility Section of the British Society of Gastroenterology who are based in 12 major research centres in the UK have been awarded a £2.1M grant from the National Institute of Health Research Efficacy and Mechanism Evaluation (NIHR EME) Programme to perform a clinical trial entitled "Treatment of IBS with diarrhoea with Titrated Ondansetron (TRITON)”. The trial will be coordinated from the Leeds Clinical Trials Research Unit and the mechanistic studies will involve specialist centres in Leeds, University College London and Barts and the London Hospital. Recruitment is expected to start in autumn 2017.
The trial offers a great opportunity for two specialist registrars to obtain a higher degree in the rapidly expanding field of neurogastroenterology. The trial will include studies of how ondansetron affects bowel motility and sensitivity. Understanding how ondansetron works will improve our ability to predict who will respond and will inform the development of new treatments for this common and distressing condition. One registrar will be based at QMC, Nottingham and the other at QMUL, London; both are expected to start their fully supported OOP work in September 2017. The posts will be advertised soon with full information on how to apply.
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