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| Name | Class |
|---|---|
| UMC Utrecht | OTHER |
| University of Southern Denmark | OTHER |
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The study aims to describe alterations in the contact activation system during active and inactive ulcerative colitis.
Contact activation system measures are compared in a cross sectional (healthy controls vs. active disease) and longitudinal (active diasese vs. inactive disease) fashion.
We include and follow up on 102 adults with active ulcerative colitis. Visits are week 0 (inclusion), 6, 12 and 26 (end of study). We obtain plasma and fecal samples at each visit. Whereas we obtain colonic tissue samples only at inclusion and end of study.
Registered data are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UC group | Patients with active ulcerative colitis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuously assessment of disease activity | Diagnostic Test | Continuous measures of disease activity and activity in the contact activation system. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical disease activity. | PRO2 score, 0-6 points. A score of one or more defines active disease. | End of study (August 28th, 2024) |
| Endoscopic disease activity. | Mayo endoscopic score, 0-3 points. A score of one or more defines active disease. | End of study (August 28th, 2024) |
| Kallikrein generation | The assay reflects the downstream activation of the contact activation system which allows us to determine the amount of kallikrein generated in each sample. | End of study (August 28th, 2024) |
| Polymerised alpha-1-antitrypsin in participants | A Western blot verifies the present of polymerised alpha-1-antitrypsin. | End of study (August 28th, 2024) |
| Polymerised alpha-1-antitrypsin as an activator of the contact activation system | We add polymerised alpha-1-antitrypsin to our kallikrein generation. If kallikrein is generated the polymers activated the system. | End of study (August 28th, 2024) |
| Localisation of contact activation system components in tissue samples | Immunhistochemical methods locate FXII, PK, cHK (specific to plasma kallikrein and tissue kallikrein), C1 Inhibitor, and Kallistatin in biopsies. | End of study (August 28th, 2024) |
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Inclusion Criteria:
Exclusion Criteria:
Pregnancy
Infection at inclusion
Any existing disease at inclusion:
Medication with
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Patients are enrolled from the Department of Medical Gastroenterology at the Hospital of Southwest Jutland, Region of Southern Denmark, Denmark
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| Name | Affiliation | Role |
|---|---|---|
| Morten L Halling, M.D. | Department of Medical Gastroenterology, University Hospital of Southern Denmark - Esbjerg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Medical Gastroenterology, University Hospital of Southern Denmark | Esbjerg | 6700 | Denmark |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| D015212 | Inflammatory Bowel Diseases |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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Plasma (EDTA and citrate) stored at -70 degrees celcius. Fecal extract stored at -70 degrees celcius. Colonic tissue snap frozen with liquid nitrogen and stored at -70 degrees celcius.
Colonic tissue fixated in formalin and embeded in parafin within 72h.
| D003108 |
| Colonic Diseases |
| D007410 | Intestinal Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |