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| Name | Class |
|---|---|
| University of Southern Denmark | OTHER |
| Aarhus University Hospital | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active RIC | Experimental | 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. |
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| Sham | Sham Comparator | As above with a cuff pressure of 20 mmHg |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AutoRIC device | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in index of clinical activity - numerical change in Mayo score including endoscopic subscore | 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in fecal calprotectin. | 10 days | |
| Change in endoscopy - central reading according to Mayo endoscopic subscore and UCEIS | 10 days | |
| Number of patients achieving clinical remission (Mayo score <3) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jens Kjeldsen, MD, PhD | Odense University Hospital | Study Chair |
| Line Godskesen | Odense University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Odense University Hospital | Odense | 5000 | Denmark |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| D005767 | Gastrointestinal Diseases |
| D010335 | Pathologic Processes |
| D007410 | Intestinal Diseases |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D004066 | Digestive System Diseases |
| D003108 | Colonic Diseases |
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| 10 days |
| Patient experience of repeated RIC (questionnaire, including placebo recognition). | 10 days |
| Change in histological score of inflammation. | 10 days |
| Changes in serum and mucosal cytokine profile in particular Th1/Th2/Th9/Th17/Th22. measured by FlowCytomix Multiplex. | 10 days |
| Changes in serum markers of inflammation (serum C-reactive protein). | 10 days |
| Changes in serum markers of extracellular matrix proteins (C1M, C3M, C4M, P1NP and VICM). | 10 days |
| Changes in serum and mucosal level of CGRP, endothelin-1, endothelin-2. | 10 days |
| Effect of RIC in patients with active ulcerative colitis using the Langendorff model (to document activation of a cardioprotective response). | 10 days |
| D013568 |
| Pathological Conditions, Signs and Symptoms |