NCT02445365

Remote Ischemic Conditioning in Patients With Ulcerative Colitis

Effect of Remote Ischemic Conditioning (RIC) on Inflammation and Remodelling of Extracellular Matrix Proteins in Patients With Inflammatory Bowel Diseases

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Odense University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colitis, Ulcerative
• Gastrointestinal Diseases
• Pathologic Processes
• Intestinal Diseases
• Inflammatory Bowel Diseases

Interventions

Type	Name	Description
DEVICE	AutoRIC device

Timeline

• Start date: 2015-05-01
• Primary completion: 2018-02-01
• Completion: 2018-02-15
• First posted: 2015-05-15
• Last updated: 2018-03-22

Locations

1 site across 1 country: Denmark