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Completed

NCT Number: NCT04621006

The Contact Activation System and Ulcerative Colitis

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.

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammation Inflammatory Bowel Diseases Intestinal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Medical Gastroenterology, University Hospital of Southern Denmark

Esbjerg, 6700, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Continuously assessment of disease activity

Diagnostic Test

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Esbjerg Hospital - University Hospital of Southern Denmark

Other

Collaborators

  • UMC Utrecht
  • University of Southern Denmark

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Nov 9, 2020
Registry last updated
Feb 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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