MODULATE Trial

Researchers at University of Leeds, funded by NIHR Health Technology Assessment, are looking for patients with stable Ulcerative Colitis who experience symptoms of diarrhoea, to take part in a study assessing the effectiveness of the low FODMAP diet, amitriptyline, loperamide and ondansetron.

Excitingly, this study is currently planning to open for recruitment in October 2020 after taking a break during the Coronavirus pandemic.

Background and study aims

Ulcerative colitis (UC) is a long-term condition where the colon and rectum become inflamed. The colon is the large intestine (bowel) and the rectum is the end of the bowel where stools are stored. Small ulcers can develop on the colon's lining, and can bleed and produce pus. About 1 in 5 people with UC report ongoing diarrhoea, even when there is no sign of bowel inflammation. This also causes discomfort and distress, reducing peoples’ quality of life, and impacting on their psychological health and mood.
This is a similar situation to people living with irritable bowel syndrome (IBS), who often experience troublesome diarrhoea. In IBS, a low diet low in poorly absorbed sugars (FODMAPs) improves diarrhoea, because some FODMAPs increase small intestinal water content. Drugs like ondansetron (an antisickness drug), amitriptyline (an antidepressant drug), or loperamide (an antidiarrhoeal drug) can also be effective in IBS with diarrhoea. This is because they change bowel activity, and can relieve tummy pain. These treatments may therefore help people with stable UC.

More detailed technical information can be found on the trial website.

Who can participate?

People aged over 18 years with stable UC who have diarrhoea.

What does the study involve?

All participants will be provided with standard first-line dietary advice. People will also be given one of the following: a low FODMAP diet; ondansetron; amitriptyline; loperamide; or no additional treatment.
A computer will randomly decide who gets which one. People will be asked to follow the diet or take the tablets for 6 months, in addition to their doctor’s usual treatment for UC. People will be aware of which treatment they get.
People will be followed up at 8 weeks and 6 months. Side effects and adherence to each treatment will be recorded as well as how many flare-ups people experience, whether usual treatment for UC has been changed, and whether surgery has been required.

What are the possible benefits and risks of participating?

Benefits - improvement in symptoms and quality of life for patients with stable UC and ongoing diarrhoea, fewer secondary care hospital visits, should help clinicians, patients and health service planners to make better-informed decisions regarding the management of diarrhoea in patients with stable UC in secondary care.
Risks - side effects associated with the drugs (although thought to be at a reduced rate due to the lower dose used).

How can I take part?

If you are interested and would like more information about the study, please contact modulate@leeds.ac.uk.


This research study is NOT funded or organised by Crohn's & Colitis UK and, therefore, we cannot take responsibility for your involvement in the research. It is a patient’s choice to take part.