Mitochondrial DAMPs as Mechanistic Biomarkers of Mucosal Inflammation in Crohn's Disease and Ulce… (NCT04760964) | Clinical Trial Compass
RecruitingNot Applicable
Mitochondrial DAMPs as Mechanistic Biomarkers of Mucosal Inflammation in Crohn's Disease and Ulcerative Colitis
United Kingdom250 participantsStarted 2021-01-27
Plain-language summary
The MUSIC study is a multi-centre, longitudinal study set in the real world IBD clinical setting to investigate and develop a new biomarker approach that aims to inform both patients and clinicians of the current state of the affected gut lining (how inflamed or whether the bowel wall has completely healed).
This new biomarker approach will study a panel of molecular signs in IBD patients' blood, stools and biopsies that will be correlated to the current gold standard of direct gut visual examination using ileo-colonoscopy and flexible sigmoidoscopy tests (a fibre-optic examination of the lower small bowel and large bowel). Here, the state and appearances of IBD patients' gut lining will be assessed over one year in response to treatment given to them by their NHS IBD consultant.
This approach will focus on the role of damage associated molecular patterns (DAMPs), also known as 'danger signals'. DAMPs are found in our own cells and are released during tissue stress or injury. Like signals from bacteria, they can trigger inflammation. In the MUSIC study, blood, stool, saliva and gut samples obtained from participants during active IBD and in clinical remission will be used in order to understand how DAMPs contribute to the development of gut inflammation.
Who can participate
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. All patients must be able to give consent and aged 16 years old and over.
✓. All patients must have a diagnosis of IBD (CD or UC)
✓. All patients must have active IBD at the time of screening:
✓. All IBD patients with disease involvement that is amenable for endoscopic assessment of mucosal healing. This includes:
✓. All IBD patients will require a recent ileo-colonoscopy or flexible sigmoidoscopy within 6 weeks of recruitment that has:
✓. If patients have undergone an ileo-colonoscopy or flexible sigmoidoscopy within 6 weeks but with an endoscopic report that is insufficient in endoscopic disease activity data as per (5), potential participant can still be considered providing there is:
Exclusion criteria
✕. IBD patients with severe/fulminant disease at screening:
✕. Referring clinician's judgement where surgical intervention (colectomy or resection) is deemed likely within 3 months of screening
✕. Evidence of intestinal dyplasia or malignancy (histologic, endoscopic or radiologic)
What they're measuring
1
The role of mitochondrial DAMPs as an indicator of gut inflammation and mucosal healing
. UC patients with limited involvement of the rectum (\<15cm - proctitis)
✕. UC patients who have had a colectomy (total and subtotal)
✕. UC patients with an ileo-anal pouch
✕. IBD (UC, CD or IBD-U) with an intestinal stoma
✕. Patients where ileo-colonoscopy or flexible sigmoidoscopy are contra-indicated (e.g. significant co-morbidities e.g. cardiovascular, respiratory, cancer, renal failure; and pregnancy)