Actively Recruiting
Mitochondrial DAMPs as Mechanistic Biomarkers of Mucosal Inflammation in Crohn's Disease and Ulcerative Colitis
Led by University of Edinburgh · Updated on 2024-06-18
250
Participants Needed
3
Research Sites
257 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Mitochondrial DAMPs as Mechanistic Biomarkers of Mucosal Inflammation in Crohn's Disease and Ulcerative Colitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to give consent and aged 16 years or older
- Diagnosed with inflammatory bowel disease (Crohn's disease or ulcerative colitis)
- Active IBD symptoms as judged by a clinician plus one of the following within 6 weeks: stool calprotectin over 100 ug/g, blood C-reactive protein over 5 mg/L, or endoscopic, radiologic, or histological evidence of active IBD
- Disease involvement suitable for endoscopic assessment, including Crohn's disease patients with prior ileal or colonic surgery, perianal disease if endoscopy is not contraindicated, or ileal involvement only
- Recent ileo-colonoscopy or flexible sigmoidoscopy within 6 weeks showing clear documentation of disease activity and extent, with photographs; or willing to undergo these procedures at baseline
- If prior endoscopy report lacks sufficient disease activity data, must have objective evidence of disease activity (calprotectin or CRP) within 2 weeks of that endoscopy
You will not qualify if you...
- Severe or fulminant IBD at screening, including colitis with stool frequency over 6 per 24 hours and features such as fever, high pulse, low hemoglobin, or low albumin
- Evidence of toxic megacolon confirmed by abdominal X-ray if clinically indicated
- Significant bowel obstruction, abdominal sepsis, abscess, or fistula as documented by clinician and supported by tests
- Surgical intervention likely within 3 months per clinician judgement
- Evidence of intestinal dysplasia or malignancy
- Ulcerative colitis limited to rectum less than 15 cm (proctitis)
- History of colectomy (total or subtotal) in ulcerative colitis patients
- Presence of an ileo-anal pouch in ulcerative colitis patients
- Presence of an intestinal stoma in IBD patients
- Contraindication to ileo-colonoscopy or flexible sigmoidoscopy such as serious comorbidities or pregnancy
- Language barriers preventing understanding of information and informed consent
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Ninewells Hospital
Dundee, United Kingdom
Not Yet Recruiting
2
Western General Hospital
Edinburgh, United Kingdom
Actively Recruiting
3
NHS Greater Glasgow & Clyde
Glasgow, United Kingdom
Not Yet Recruiting
Research Team
G
Gwo-Tzer Ho
CONTACT
E
Emma Ward
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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