Ulcerative colitis (UC) is a chronic relapsing inflammatory bowel disease (IBD). At the time of diagnosis it is not possible to predict the course of the disease, which can range from a few flares in a lifetime to uncontrollable disease leading to hospitalization, surgery and stoma. There is a continuous need to improve treatment as well as diagnostic and prognostic tools. This study evaluates the clinical efficacy, tolerability and feasibility of remote ischemic conditioning (RIC) in patients with moderate active ulcerative colitis (UC). The investigators hypothesize that RIC beyond the well known effect on reperfusion tissue damage has a clinically relevant anti-inflammatory effect in UC. RIC constitute a repeated brief and non-harmful suppression of blood circulation in a limb. The mechanism of action of RIC is likely to involve suppressed inflammation and cell death. Our study is a randomized clinical controlled study including 38 patients. Patients will receive RIC or sham for 10 consecutive days. The effect of RIC on active UC is evaluated by changes patient's symptoms, endoscopy findings, and various markers in the blood, faeces and the intestinal wall.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Enrollment
22
Odense University Hospital
Odense, Denmark
Change in index of clinical activity - numerical change in Mayo score including endoscopic subscore
Time frame: 10 days
Change in fecal calprotectin.
Time frame: 10 days
Change in endoscopy - central reading according to Mayo endoscopic subscore and UCEIS
Time frame: 10 days
Number of patients achieving clinical remission (Mayo score <3)
Time frame: 10 days
Patient experience of repeated RIC (questionnaire, including placebo recognition).
Time frame: 10 days
Change in histological score of inflammation.
Time frame: 10 days
Changes in serum and mucosal cytokine profile in particular Th1/Th2/Th9/Th17/Th22. measured by FlowCytomix Multiplex.
Time frame: 10 days
Changes in serum markers of inflammation (serum C-reactive protein).
Time frame: 10 days
Changes in serum markers of extracellular matrix proteins (C1M, C3M, C4M, P1NP and VICM).
Time frame: 10 days
Changes in serum and mucosal level of CGRP, endothelin-1, endothelin-2.
Time frame: 10 days
Effect of RIC in patients with active ulcerative colitis using the Langendorff model (to document activation of a cardioprotective response).
Time frame: 10 days
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