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Management of diarrhoea in ulcerative colitis: A multi-arm, multi-stage trial of low FODMAP diet, amitriptyline, ondansetron, or loperamide
MODULATE is a study hoping to identify effective treatments for ongoing diarrhoea in people with stable ulcerative colitis. The study is offering treatment that hasn't been offered in this area before, and hopes to address an unmet need for those who currently have no available treatment.
MODULATE is a remote trial, meaning that you can consent to take part, provide samples, attend online or telephone appointments, and fill in study questionnaires all from the comfort of your own home! Those who consent to take part will be randomised to receive study medication, a dietary intervention, or continue with usual care. Those who take part may have medication posted to them and/or will have online or telephone appointments, so there is no need to go to the hospital for physical appointments. This makes the study accessible to those with UC who are on immuno suppressants and/or clinically vulnerable.
If you have stable ulcerative colitis and are suffering from diarrhoea, despite being on the correct treatment for your condition, you may be eligible for this study. You can also fill out the self-screening questionnaire on the website, if you are unsure of your eligibility.
As a patient with UC myself, who had the experience of being diagnosed with ‘stable disease’ and yet continuing to have bowel symptoms, it was extremely distressing and frustrating knowing there were several treatments available that are known to manage diarrhoea, but which were unable to be prescribed because they hadn’t been tested in patients with UC. I welcome this trial wholeheartedly as it has the potential to provide up to four new treatment options that could ease the suffering of patients who currently have no treatment at all for their symptoms.
EMMA PRYDE,
Patient Representative and Crohn's & Colitis UK Research Champion
Visit the trial websitefor more information, to see participating sites and to sign up to get involved.
You can also follow the MODULATE trial on Twitter.
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We know it can be difficult to live with, or support someone living with these conditions. But you’re not alone. We provide up-to-date, evidence-based information and can support you to live well with Crohn’s or Colitis.
Our helpline team can help by:
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