The Contact Activation System and Ulcerative Colitis

NCT04621006 | Completed

• 1 other identifier: CAS UC
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

Brief 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.

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; Inflammation

Outcome Measures

Primary Outcomes (6)

• 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)

Study Arms (1)

UC group

Patients with active ulcerative colitis

Diagnostic Test: Continuously assessment of disease activity

Interventions

Continuously assessment of disease activity DIAGNOSTIC_TEST

Continuous measures of disease activity and activity in the contact activation system.

UC group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients are enrolled from the Department of Medical Gastroenterology at the Hospital of Southwest Jutland, Region of Southern Denmark, Denmark

You may qualify if:

• 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

You may not qualify if:

• Pregnancy
• liver disease or defect in CAS
• inflammatory rheumatologic or dermatologic disease
• cardiovascular or renal disease
• immunodeficiency or hematologic diseases
• malignancies
• Medication with
• ACE-inhibitor
• Acetylsalicylic acid/NSAID
• Warfarin, Phenprocoumon, NOAC and heparins

Sponsors & Collaborators

• Esbjerg Hospital - University Hospital of Southern Denmark: lead
• UMC Utrecht: collaborator
• University of Southern Denmark: collaborator

Study Sites (1)

Department of Medical Gastroenterology, University Hospital of Southern Denmark

Esbjerg, 6700, Denmark

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

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.

MeSH Terms

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases; Inflammation

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Morten L Halling, M.D.

  Department of Medical Gastroenterology, University Hospital of Southern Denmark - Esbjerg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 3, 2020
• First Posted: November 9, 2020
• Study Start: May 1, 2021
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: February 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)