An observational study in Ulcerative Colitis, sponsored by Esbjerg Hospital - University Hospital of Southern Denmark. Completed at 1 site in Denmark. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-25.
Sponsored by Esbjerg Hospital - University Hospital of Southern Denmark · Observational
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:
1,530 studies on the registry are indexed under Colitis, Ulcerative; 407 are open to participants now.
This study's enrollment of 102 is below the median of 158 across 404 observational studies indexed under Colitis, Ulcerative.
Browse Colitis, Ulcerative studies →Esbjerg Hospital - University Hospital of Southern Denmark is the lead sponsor of 49 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients are enrolled from the Department of Medical Gastroenterology at the Hospital of Southwest Jutland, Region of Southern Denmark, Denmark
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Any existing disease at inclusion:
Medication with
Patients with active ulcerative colitis
Diagnostic Test: Continuously assessment of disease activity
Continuous measures of disease activity and activity in the contact activation system.
Clinical disease activity.
PRO2 score, 0-6 points. A score of one or more defines active disease.
Time frame: End of study (August 28th, 2024)
Endoscopic disease activity.
Mayo endoscopic score, 0-3 points. A score of one or more defines active disease.
Time frame: 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.
Time frame: End of study (August 28th, 2024)
Polymerised alpha-1-antitrypsin in participants
A Western blot verifies the present of polymerised alpha-1-antitrypsin.
Time frame: 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.
Time frame: 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.
Time frame: End of study (August 28th, 2024)
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Esbjerg Hospital - University Hospital of Southern Denmark