Short summary

Part 1 evaluates the clinical efficacy, tolerability and feasibility of remote ischemic conditioning (RIC) in patients with moderate active ulcerative colitis (UC). We hypothesize that RIC, beyond the well-known effect on reperfusion tissue damage, has a clinically relevant anti-inflammatory effect in UC. The study is a clinical, randomized study including 38 patients.

Part 2 evaluates new biomarkers of the extracellular matrix turnover in regards to diagnostic and prognostic value in UC and Crohn's Disease (CD). A prospective study including 200 patients with UC and CD, 100 patients with irritable bowel syndrome and 100 healthy controls.

Rationale

Part 1:

We 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 RIC is incompletely understood, but likely involves suppression of inflammation and cell death.

Part 2:

Inflammation is a dynamic process with a permanent remodelling of the extracellular matrix (ECM).  Small protein fragments of the ECM generated during this process are released into the blood stream. The study will evaluate if the protein fragments can be used as biochemical markers of disease activity in patients with IBD, as well as diagnostic and prognostic markers of IBD.

Description of the cohort

Part 1:

38 patients with moderate active ulcerative colitis Disease activity is defined by Mayo-score >6. Patients are included from the outpatient clinic at The Department of Gastroenterology, Odense University Hospital. Inclusion period from 2015 to 2017.

Part 2:

The cohort will consist of 200 patients with ulcerative colitis and Crohn's disease. Disease activity ranging from complete remission to severe flare-up. 100 patients with irritable bowel syndrome. All of the patients are included from the outpatient clinic at The Department of Gastroenterology, Odense University Hospital in a period from 2015 -2018. Furthermore, 100 healthy controls fund by advertising.

Data and biological material

Blood, faeces and biopsies from the sigmoideum are collected as well as data on patients' medical history, demographic data, and current symptoms are collected.

Collaborating researchers and departments

Department of Cardiology B, Aarhus University Hospital

• Professor and Senior Hospital Physician Hans Erik Bøtker, PhD, MD
• Michael Rahbek Schmidt, MD, PhD

Institute of Molecular Medicine, University of Southern Denmark

• Professor of Medical Molecular Pharmacology Jo De Mey

Nordic Bioscience A/S, Biomarkers & Research, Herlev

• Principal Scientist and Head of Rheumatology Anne-Christine Bay-Jensen, MBA, MSc, PhD
• PhD-student Joachim Høg Mortensen, MSc