Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
47

Summary

Conditions
Ulcerative Colitis
Type
Observational
Design
Observational Model: CohortTime Perspective: Prospective

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

The study is a part of a Ph.d. project anchored at the Department of Medical Gastroenterology and the Unit of Thrombosis Research at the University Hospital of Southern Denmark - Esbjerg. A total of 47 participants with active disease are to be followed in a prospective cohort study for 26 weeks. Th...

The study is a part of a Ph.d. project anchored at the Department of Medical Gastroenterology and the Unit of Thrombosis Research at the University Hospital of Southern Denmark - Esbjerg. A total of 47 participants with active disease are to be followed in a prospective cohort study for 26 weeks. The study will describe differences between active and inactive disease. Data obtained from all participants are demographics assessment of quality of life (SIBDQ questionnaire) assessment of disease activity (SCCAI questionnaire, PRO 2 questionnaire, endoscopic Mayo score, histologic score by the Nancy index, c-reactive peptide and fecal calprotectin) assessment of the concentration and activity of the contact activation system proteins assessment of misfolded alpha-1-antitrypsin. assessment of ER stress (GRP78/BiP) The endoscopic and histologic assessment serve as the gold standard. Medias analyzed are blood, stool and colonic tissue.

Tracking Information

NCT #
NCT04621006
Collaborators
  • University of Southern Denmark
  • UMC Utrecht
  • Odense University Hospital
  • Sygehus Lillebaelt
Investigators
Principal Investigator: Morten L Halling, M.D. Department of Medical Gastroenterology, University Hospital of Southern Denmark - Esbjerg