Researchers from the Gastroenterology Section of the Leeds Institute for Biomedical and Clinical Sciences, University of Leeds, the Clinical Trials Research Unit (CTRU) at Leeds Institute of Clinical Trials Research (LICTR), the Department of Gastroenterology at the Royal Wolverhampton NHS Trust, the Department of Gastroenterology at the Royal Liverpool and Broadgreen University Hospitals Trust, and the Department of Gastroenterology at the Royal Devon and Exeter NHS Foundation Trust have received £1.5 million of funding from the National Institute for Health Research Health Technology Assessment (NIHR HTA) programme to conduct a multi-arm multi-stage trial of low FODMAP diet, amitriptyline, ondansetron, or loperamide, versus standard dietary advice as a treatment for ongoing diarrhoea in stable ulcerative colitis in secondary care.
Led by Professor Alexander Ford, the research team comprises Professor Amanda Farrin, Professor Else Guthrie, Professor Lesley Houghton, Dr. Tom Morris, Ms. Suzanne Hartley, and Ms. Delia Muir from the University of Leeds, Professor Matthew Brookes from the Royal Wolverhampton NHS Trust, Professor Chris Probert from the Royal Liverpool and Broadgreen University Hospitals Trust, Dr. Nick Kennedy from the Royal Devon and Exeter NHS Foundation Trust, Ms. Yvonne McKenzie, specialist dietitian in Oxford, and Mrs. Emma Pryde, who will provide patient and public involvement.
The study, known as MODULATE (Management of diarrhoea in ulcerative colitis: multi-arm multi-stage trial of low FODMAP diet, amitriptyline, ondansetron, or loperamide), will involve up to 490 people with stable ulcerative colitis who report ongoing troublesome diarrhoea in secondary care. Participants will be recruited across approximately 25 centres within England, Scotland, and Wales over 24 months in total.
Alexander Ford, Professor of Gastroenterology at the University of Leeds and Honorary Consultant Gastroenterologist at Leeds Teaching Hospitals NHS Trust said: “Up to one-quarter of people with ulcerative colitis will report ongoing diarrhoea, even when their level of medical therapy is felt to be appropriate, and there is no sign of active inflammation. However, no one knows how best to manage this problem because there have been no randomised controlled trials comparing the interventions we are proposing. If one or more of them proves to be effective, the results of our study will therefore be of considerable importance for people living with ulcerative colitis, their families, the NHS, and society as a whole. ”