The Contact Activation System and Ulcerative Colitis

Ulcerative Colitis Clinical Trial

Official title:

The Contact Activation System and Ulcerative Colitis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04621006
• Other study ID #: CAS UC
• Status: Active, not recruiting
• Start date: May 1, 2021
• Est. completion date: August 27, 2024

Study information

• Verified date: December 2023
• Source: Hospital of South West Jutland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 102
• Est. completion date: August 27, 2024
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Diagnostic Test:
• Continuously assessment of disease activity
Continuous measures of disease activity and activity in the contact activation system.

Locations

Country	Name	City	State
Denmark	Department of Medical Gastroenterology, University Hospital of Southern Denmark	Esbjerg

Sponsors (3)

Lead Sponsor	Collaborator
Hospital of South West Jutland	UMC Utrecht, University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical disease activity.	PRO2 score, 0-6 points. A score of one or more defines active disease.	End of study (August 28th, 2024)
Primary	Endoscopic disease activity.	Mayo endoscopic score, 0-3 points. A score of one or more defines active disease.	End of study (August 28th, 2024)
Primary	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)
Primary	Polymerised alpha-1-antitrypsin in participants	A Western blot verifies the present of polymerised alpha-1-antitrypsin.	End of study (August 28th, 2024)
Primary	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)
Primary	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)