Remote Ischemic Conditioning in Patients With Ulcerative Colitis
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.
|Colitis, Ulcerative Gastrointestinal Diseases Pathologic Processes Intestinal Diseases Inflammatory Bowel Diseases||Device: AutoRIC device|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Basic Science
|Official Title:||Effect of Remote Ischemic Conditioning (RIC) on Inflammation and Remodelling of Extracellular Matrix Proteins in Patients With Inflammatory Bowel Diseases|
- 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 ]
|Study Start Date:||May 2015|
|Estimated Study Completion Date:||April 2017|
|Estimated Primary Completion Date:||March 2017 (Final data collection date for primary outcome measure)|
Experimental: Active RIC
Daily remote ischemic conditioning for 10 days. Remote ischemic conditioning is induced by placing a blood pressure cuff around the right or left arm. The cuff is inflated to 200 mmHg and the pressure is kept for 5 minutes. Hereafter the cuff is deflated for 5 minutes completing one cyclus. This cyclus is repeated 4 times.
|Device: AutoRIC device|
Sham Comparator: Sham
As above with a cuff pressure of 20 mmHg
|Device: AutoRIC device|
Please refer to this study by its ClinicalTrials.gov identifier: NCT02445365
|Contact: Line Godskesen, MD||+ 45 65 41 27 email@example.com|
|Contact: Jens Kjeldsen, MD, PhD||+ 45 65 41 27 firstname.lastname@example.org|
|Odense University Hospital||Recruiting|
|Odense, Denmark, 5000|
|Contact: Line Godskesen, MD + 45 24 80 81 09 email@example.com|
|Study Chair:||Jens Kjeldsen, MD, PhD||Odense University Hospital|
|Principal Investigator:||Line Godskesen||Odense University Hospital|