Ulcerative ColitisNCT04621006
The Contact Activation System and Ulcerative Colitis
An observational study of Ulcerative Colitis, run by Esbjerg Hospital - University Hospital of Southern Denmark at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Continuously assessment of disease activity
- How many people
- 102 participants
- Where
- 1 siteDenmark
- Study dates
- 1 May 2021to 30 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients are enrolled from the Department of Medical Gastroenterology at the Hospital of Southwest Jutland, Region of Southern Denmark, Denmark
Who may be able to join
- 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
Who cannot join
- Pregnancy
- Infection at inclusion
- Any existing disease at inclusion:
- liver disease or defect in CAS
- inflammatory rheumatologic or dermatologic disease
- cardiovascular or renal disease
Show all 13Show fewer
- immunodeficiency or hematologic diseases
- malignancies
- Medication with
- Systemic corticosteroids at inclusion
- ACE-inhibitor
- Acetylsalicylic acid/NSAID
- Warfarin, Phenprocoumon, NOAC and heparins
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Medical Gastroenterology, University Hospital of Southern Denmark
Esbjerg, 6700
About this study
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.
Read the detailed description
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:
- Demographics realate to UC and general wellbeing.
- Clinical parametres used for UC evaluation are PRO2, SCCAI, CRP, fecal calprotectin, Mayo endoscopic subscore and Nancy index.
- The contact activation system is characterised by FXII, prekallikrein, kallikrein generation, HK, cHK (specific to plasma kallikrein), cHK (specific to tissue kallikrein), C1 inhibitor and Kallistatin.
- Polymerized alpha-1-antitrypsin is characterised by the degree of polymerization and the capacity to activate the contact activation system.
- Conditions
- Ulcerative Colitis
- Being tested
- Continuously assessment of disease activity
- Keywords
- Misfolded protein, Coagulation Factor XII, Kallikrein, High Molecular Weight Kininogen, The contact activation system, Endoplasmatic reticulum stress, Misfolded alpha-1-antitrypsin, Inflammatory bowel disease, Inflammation
- Medical subject headings
- Colitis, Ulcerative, Inflammatory Bowel Diseases, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuously assessment of disease activityDiagnostic test
Continuous measures of disease activity and activity in the contact activation system.
| Study group | Role | What they receive |
|---|---|---|
| UC group | Patients with active ulcerative colitis Receives: Diagnostic Test: Continuously assessment of disease activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical disease activity.
PRO2 score, 0-6 points. A score of one or more defines active disease.
Measured: End of study (August 28th, 2024)
Endoscopic disease activity.
Mayo endoscopic score, 0-3 points. A score of one or more defines active disease.
Measured: 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.
Measured: End of study (August 28th, 2024)
Polymerised alpha-1-antitrypsin in participants
A Western blot verifies the present of polymerised alpha-1-antitrypsin.
Measured: 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.
Measured: 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.
Measured: End of study (August 28th, 2024)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2020
- Study start1 May 2021
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Esbjerg Hospital - University Hospital of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- UMC Utrecht, University of Southern Denmark
- Responsible party
- Principal investigator, Morten Lee Halling, Esbjerg Hospital - University Hospital of Southern Denmark
- Investigators
- Morten L Halling, M.D., Principal investigator, Department of Medical Gastroenterology, University Hospital of Southern Denmark - Esbjerg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04621006
- Sponsor's protocol ID
- CAS UC
- Status last verified
- Feb 2025
- First submitted
- 3 Nov 2020
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Contact Activation System and Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT04621006
- Acronym / sponsor ID
- CAS UC
- Conditions
- Ulcerative Colitis
- Keywords
- Misfolded protein, Coagulation Factor XII, Kallikrein, High Molecular Weight Kininogen, The contact activation system, Endoplasmatic reticulum stress, Misfolded alpha-1-antitrypsin, Inflammatory bowel disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Esbjerg Hospital - University Hospital of Southern DenmarkUniversity, hospital or other
- Collaborators
- UMC Utrecht, University of Southern Denmark
- Study start
- 1 May 2021 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 9 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Demographics realate to UC and general wellbeing.
- Clinical parametres used for UC evaluation are PRO2, SCCAI, CRP, fecal calprotectin, Mayo endoscopic subscore and Nancy index.
- The contact activation system is characterised by FXII, prekallikrein, kallikrein generation, HK, cHK (specific to plasma kallikrein), cHK (specific to tissue kallikrein), C1 inhibitor and Kallistatin.
- Polymerized alpha-1-antitrypsin is characterised by the degree of polymerization and the capacity to activate the contact activation system.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UC group | – | Diagnostic Test: Continuously assessment of disease activityPatients with active ulcerative colitis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients are enrolled from the Department of Medical Gastroenterology at the Hospital of Southwest Jutland, Region of Southern Denmark, Denmark
Key inclusion criteria (6 listed)
- Fulfill diagnostic criteria of ulcerative colitis
- SCCAI score ≥ 5
- Mayo Endoscopic Subscore ≥ 1
- Age ≥ 18 years
- Most understand written and oral information in Danish
Key exclusion criteria (13 listed)
- Pregnancy
- Infection at inclusion
- Any existing disease at inclusion:
- Medication with
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuously assessment of disease activityContinuous measures of disease activity and activity in the contact activation system. | Diagnostic test | UC group |
Primary outcome
Clinical disease activity.
Time frame: End of study (August 28th, 2024)
PRO2 score, 0-6 points. A score of one or more defines active disease.
Endoscopic disease activity.
Time frame: End of study (August 28th, 2024)
Mayo endoscopic score, 0-3 points. A score of one or more defines active disease.
Kallikrein generation
Time frame: End of study (August 28th, 2024)
The assay reflects the downstream activation of the contact activation system which allows us to determine the amount of kallikrein generated in each sample.
Polymerised alpha-1-antitrypsin in participants
Time frame: End of study (August 28th, 2024)
A Western blot verifies the present of polymerised alpha-1-antitrypsin.
Polymerised alpha-1-antitrypsin as an activator of the contact activation system
Time frame: End of study (August 28th, 2024)
We add polymerised alpha-1-antitrypsin to our kallikrein generation. If kallikrein is generated the polymers activated the system.
Localisation of contact activation system components in tissue samples
Time frame: End of study (August 28th, 2024)
Immunhistochemical methods locate FXII, PK, cHK (specific to plasma kallikrein and tissue kallikrein), C1 Inhibitor, and Kallistatin in biopsies.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Morten L Halling, M.D. principal investigator
Department of Medical Gastroenterology, University Hospital of Southern Denmark - Esbjerg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcerative Colitis, run by Esbjerg Hospital - University Hospital of Southern Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical disease activity. (time frame: End of study (August 28th, 2024)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.