MODULATE – Management of diarrhoea in ulcerative colitis

MODULATE (Management of diarrhoea in ulcerative colitis: multi-arm multi stage of low FODMAP diet, amitriptyline, ondansetron, or loperamide) aims to identify effective treatments for ongoing diarrhoea in patients with stable Ulcerative Colitis(UC).

For people with UC, residual problems of diarrhoea and urgency even during periods when the inflammatory component of the disease is in stable remission can have a major effect on quality of life, adversely impacting both physical and emotional wellbeing.  However, the best treatment for these symptoms, which are common, is currently unclear.

The MODULATE study aims to recruit 30-60patients from the IBD BioResource whose UC is stable but who are nonetheless symptomatic with diarrhoea. Using a ‘randomised control trial’ we will compare a number of different potential treatments which are known to be effective in another clinical condition characterised by chronic diarrhoea, namely Irritable Bowel Syndrome or IBS, and assess their effectiveness. These treatment interventions are: a diet low in fermentable oligo-, di-, and mono-saccharides and polyols (FODMAPs) (known as the Low FODMAP Diet), the anti-emetic ondansetron, low-dose tricyclic antidepressant (TCA)-amitriptyline, the anti-diarrhoeal drug loperamide. All of these treatments are known to slow colonic transit and relieve tummy pain in patients with IBS, but their effect in UC has never been systematically studied.

The MODULATE study aims to see if these IBS treatments are effective in relieving diarrhoea symptoms in people with stable UC. We hope that the results will lead to more effective treatments for these troublesome symptoms in this patient group.