MODULATE – Management of diarrhoea in ulcerative colitis

Study code

Lead researcher
Professor Alexander Ford

Study type
Participant re-contact

Institution or company
University of Leeds

Researcher type

Speciality area

Recruitment Site


MODULATE (Management of diarrhoea in ulcerative colitis: A multi-arm, multi stage trial of low FODMAP diet, amitriptyline, ondansetron, or loperamide) aims to identify effective treatments for ongoing diarrhoea in patients who have an inflammatory bowel disease called 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.

A potential approach may be to use existing treatments that work in other conditions for example, irritable bowel syndrome (IBS). Many people with IBS also suffer with chronic diarrhoea and there are treatments available to help them. One of those treatments is a special diet known as the low FODMAP diet. Several drugs are also used to treat diarrhoea in IBS, including low-dose tricyclic antidepressants (TCAs), such as amitriptyline, the anti-sickness drug ondansetron, and the anti-diarrhoeal drug loperamide. All of these treatments are known to slow down the flow of digested food down the gut, improving diarrhoea and other related symptoms.

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.