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
1 other identifier
interventional
22
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 12, 2015
CompletedFirst Posted
Study publicly available on registry
May 15, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 15, 2018
CompletedMarch 22, 2018
March 1, 2018
2.8 years
May 12, 2015
March 21, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in index of clinical activity - numerical change in Mayo score including endoscopic subscore
10 days
Secondary Outcomes (10)
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)
10 days
Patient experience of repeated RIC (questionnaire, including placebo recognition).
10 days
Change in histological score of inflammation.
10 days
- +5 more secondary outcomes
Study Arms (2)
Active RIC
EXPERIMENTALDaily 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.
Sham
SHAM COMPARATORAs above with a cuff pressure of 20 mmHg
Interventions
Eligibility Criteria
You may qualify if:
- Age:≥18 years
- Verified ulcerative colitis diagnosis according to clinical, endoscopic and histological standard criteria.
- Diagnosis of ulcerative colitis established for at least 6 months
- Moderate active ulcerative colitis, total Mayo score \> 6
- Endoscopic subscore activity grade ≥1
- Written informed consent
You may not qualify if:
- Pancolitis or acute severe ulcerative colitis requiring immediate treatment
- Need for admission due to active ulcerative colitis
- Ulcerative colitis with systemic symptoms (abdominal pain, fever \> 37.5 degrees, weight loss exceeding 3 kilograms).
- Patient with anemia (Haemoglobin \< 8.3 mmol/l for males and \< 7.3 mmol/l for females).
- Patient with ostomy or pouch.
- The patient has had a bowel resection (except appendectomy)
- The patient has constipation and/or another known bowel condition than ulcerative colitis such as IBS.
- The patient has diabetes.
- Regular intake of acetylsalicylic acid or NSAIDs
- The patient cannot understand the information material.
- The patient has had colon cancer, dysplasia or adenomatous polyps in the colon during the recent 5 year
- The patient is in a poor general condition.
- The patient has had a food poisoning within the last three months.
- The patient is in medical treatment with cyclosporine at the beginning of the run in period.
- Treatment for ulcerative colitis treatment has been changed within two weeks before the first day in the run in period
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Odense University Hospitallead
- University of Southern Denmarkcollaborator
- Aarhus University Hospitalcollaborator
Study Sites (1)
Odense University Hospital
Odense, 5000, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jens Kjeldsen, MD, PhD
Odense University Hospital
- PRINCIPAL INVESTIGATOR
Line Godskesen
Odense University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Registrar, PhD student
Study Record Dates
First Submitted
May 12, 2015
First Posted
May 15, 2015
Study Start
May 1, 2015
Primary Completion
February 1, 2018
Study Completion
February 15, 2018
Last Updated
March 22, 2018
Record last verified: 2018-03