Remote Ischemic Conditioning in Patients With Ulcerative Colitis (NCT02445365) | Clinical Trial Compass
CompletedNot Applicable
Remote Ischemic Conditioning in Patients With Ulcerative Colitis
Denmark22 participantsStarted 2015-05
Plain-language 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.
Who can participate
Age range
18 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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 pregnant at the time of inclusion or has planned pregnancy during the period of study.
* The patient is in medical treatment with cyclosporine at the beginning of the run in period.
* Treatment for ulcerative colitis tr…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in index of clinical activity - numerical change in Mayo score including endoscopic subscore