CompletedNot Applicable

The Contact Activation System and Ulcerative Colitis

Denmark102 participantsStarted 2021-05-01

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

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: * Fulfill diagnostic criteria of ulcerative colitis * SCCAI score ≥ 5 * Mayo Endoscopic Subscore ≥ 1 * Age ≥ 18 years * Most understand written and oral information in Danish * Informed consent must be given Exclusion Criteria: * Pregnancy * Infection at inclusion * Any existing disease at inclusion: * liver disease or defect in CAS * inflammatory rheumatologic or dermatologic disease * cardiovascular or renal disease * immunodeficiency or hematologic diseases * malignancies * Medication with * Systemic corticosteroids at inclusion * ACE-inhibitor * Acetylsalicylic acid/NSAID * Warfarin, Phenprocoumon, NOAC and heparins

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Clinical disease activity.

Timeframe: End of study (August 28th, 2024)

Endoscopic disease activity.

Timeframe: End of study (August 28th, 2024)

Kallikrein generation

Timeframe: End of study (August 28th, 2024)

Polymerised alpha-1-antitrypsin in participants

Timeframe: End of study (August 28th, 2024)

Polymerised alpha-1-antitrypsin as an activator of the contact activation system

Timeframe: End of study (August 28th, 2024)

Localisation of contact activation system components in tissue samples

Timeframe: End of study (August 28th, 2024)

Trial details

NCT IDNCT04621006

SponsorEsbjerg Hospital - University Hospital of Southern Denmark

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-11-30

View on ClinicalTrials.gov More Ulcerative Colitis trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Clinical disease activity.

Timeframe: End of study (August 28th, 2024)

Endoscopic disease activity.

Timeframe: End of study (August 28th, 2024)

Kallikrein generation

Timeframe: End of study (August 28th, 2024)

Polymerised alpha-1-antitrypsin in participants

Timeframe: End of study (August 28th, 2024)

Polymerised alpha-1-antitrypsin as an activator of the contact activation system

Timeframe: End of study (August 28th, 2024)

Localisation of contact activation system components in tissue samples

Timeframe: End of study (August 28th, 2024)