The MODULATE Trial

MODULATE
Management of diarrhoea in ulcerative colitis: A multi-arm, multi-stage trial of low FODMAP diet, amitriptyline, ondansetron, or loperamide

About 1 in 5 people with stable UC report ongoing diarrhoea, which is a similar situation to people living with IBS. In IBS, a low diet low in poorly absorbed sugars (FODMAPs) improves diarrhoea and drugs like ondansetron, amitriptyline, or loperamide can also be effective. These treatments may therefore help people with stable UC.

About 1 in 5 patients with ulcerative colitis (UC) often still experience frequent, troublesome diarrhoea, even when there is no sign of bowel inflammation. This can cause discomfort and distress, reducing people’s quality of life, and impacting on their psychological health and mood. This is a similar situation to people living with irritable bowel syndrome (IBS) with diarrhoea. The MODULATE study looks to use treatments that are effective in IBS with diarrhoea, such as a diet low in poorly absorbed sugars (FODMAPs), the anti-sickness drug ondansetron, a low dose of the antidepressant drug amitriptyline, and the anti-diarrhoeal drug loperamide, to see if they can reduce the diarrhoeal symptoms and improve quality of life for patients with UC living with diarrhoea.

Patients who are interested in the study will have an eligibility assessment that will include:

  1. Providing blood and stool samples, and
  2. Answering some questions about their UC.

If eligible for MODULATE, participants will be randomly allocated to 1 of 5 study groups. Depending on which group they are allocated to, participants may be contacted more frequently to answer some questions or to receive instructions from a research nurse or dietitian. All participants will be asked to complete a questionnaire booklet 8 weeks after being randomly allocated to a study group. Participants will be asked to repeat this at 6 months and to provide another blood and stool sample.

As MODULATE is a multi-stage study, patients joining the study later may be allocated to 1 of only 2 or 3 groups because, after a certain point, at least 2 of the treatment groups (diet or drug) will be removed from the trial as they are thought to be the least likely to be effective.

MODULATE will recruit participants for 25 months from 26 UK hospitals. Hospitals currently seeing patients for the MODULATE study can be found on the trial website, as well as more information about the trial.

You can also follow the MODULATE trial on Twitter!