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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02445365
Other study ID # S-20140133
Secondary ID
Status Completed
Phase N/A
First received May 12, 2015
Last updated March 21, 2018
Start date May 2015
Est. completion date February 15, 2018

Study information

Verified date March 2018
Source Odense University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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Study Design


Intervention

Device:
AutoRIC device


Locations

Country Name City State
Denmark Odense University Hospital Odense

Sponsors (3)

Lead Sponsor Collaborator
Odense University Hospital Aarhus University Hospital, University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in index of clinical activity - numerical change in Mayo score including endoscopic subscore 10 days
Secondary Change in fecal calprotectin. 10 days
Secondary Change in endoscopy - central reading according to Mayo endoscopic subscore and UCEIS 10 days
Secondary Number of patients achieving clinical remission (Mayo score <3) 10 days
Secondary Patient experience of repeated RIC (questionnaire, including placebo recognition). 10 days
Secondary Change in histological score of inflammation. 10 days
Secondary Changes in serum and mucosal cytokine profile in particular Th1/Th2/Th9/Th17/Th22. measured by FlowCytomix Multiplex. 10 days
Secondary Changes in serum markers of inflammation (serum C-reactive protein). 10 days
Secondary Changes in serum markers of extracellular matrix proteins (C1M, C3M, C4M, P1NP and VICM). 10 days
Secondary Changes in serum and mucosal level of CGRP, endothelin-1, endothelin-2. 10 days
Secondary Effect of RIC in patients with active ulcerative colitis using the Langendorff model (to document activation of a cardioprotective response). 10 days
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