Mitochondrial DAMPs as Mechanistic Biomarkers of Mucosal Inflammation in Crohn's Disease and Ulcerative Colitis (MUSIC)
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|ClinicalTrials.gov Identifier: NCT04760964|
Recruitment Status : Recruiting
First Posted : February 18, 2021
Last Update Posted : February 26, 2021
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.
|Condition or disease|
|Inflammatory Bowel Diseases|
|Study Type :||Observational|
|Estimated Enrollment :||250 participants|
|Official Title:||Mitochondrial DAMPs as Mechanistic Biomarkers of Mucosal Inflammation in Crohn's Disease and Ulcerative Colitis (MUSIC)|
|Actual Study Start Date :||January 27, 2021|
|Estimated Primary Completion Date :||February 28, 2023|
|Estimated Study Completion Date :||February 28, 2023|
- The role of mitochondrial DAMPs as an indicator of gut inflammation and mucosal healing [ Time Frame: 12 months ]To investigate the role of mitochondrial DAMPs in the clinic as an indicator of gut inflammation and subsequent mucosal healing in response to medical treatment in IBD.
Biospecimen Retention: Samples With DNA
SALIVA: 1 sample for DNA sampling. BLOOD: At each time point, ~40mls of blood will be taken. Serum for normal IBD care and Mediators/Biomarkers, Serum proteins and LC-MS EDTA tubes for normal IBD care and Mediators/metabolites/biomarkers RNA tube (PAXgene®) for RNA sequencing of host transcriptome ILEO-COLONOSCOPY SAMPLES: Standard research sampling involves: 4 biopsies (2 for formalin fixation and 2 for RNA-later) from ileum (the small bowel), caecum, transverse colon and rectum respectively. Total of 16 biopsies.
STOOL SAMPLES: For Microbiome Next Generation Sequencing/Calprotectin/Stool biomarkers and faecal immunochemical test (FIT)
In selected patients:
BLOOD SAMPLES: 10-20 participants with anticipated high DAMP release. ~10-20 IBD patients with inactive, quiescent disease.
SURGICAL SAMPLES: Surplus tissue may be obtained from specimens of the colon and ileum that have been surgically removed either at the time of operation or during histopathological evaluation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04760964
|Contact: Gwo-Tzer Ho||01312426653||G.Ho@ed.ac.uk|
|Contact: Emma Wardfirstname.lastname@example.org|
|Ninewells Hospital||Not yet recruiting|
|Dundee, United Kingdom|
|Contact: Craig Mowat email@example.com|
|Principal Investigator: Craig Mowat|
|Western General Hospital||Recruiting|
|Edinburgh, United Kingdom|
|Contact: Gwo-Tzer Ho G.Ho@ed.ac.uk|
|Principal Investigator: Gwo-Tzer Ho|
|NHS Greater Glasgow & Clyde||Not yet recruiting|
|Glasgow, United Kingdom|
|Contact: John Paul Seenan firstname.lastname@example.org|
|Principal Investigator: John Paul Seenan|
|Principal Investigator:||Gwo-Tzer Ho||University of Edinburgh|