Remote Ischemic Conditioning in Patients With Ulcerative Colitis

NCT ID: NCT02445365

Last Updated: 2018-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2018-02-15

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Active RIC

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.

Group Type: EXPERIMENTAL

AutoRIC device

Intervention Type: DEVICE

Sham

As above with a cuff pressure of 20 mmHg

Group Type: SHAM_COMPARATOR

AutoRIC device

Intervention Type: DEVICE

Interventions

AutoRIC device

Intervention Type: DEVICE

Eligibility Criteria

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 treatment has been changed within two weeks before the first day in the run in period
• The patient has commenced treatment with azathioprine, 6-mercaptopurine or methotrexate within 12 weeks before the first day in the run in period.
• The patient has commenced treatment with TNF-α inhibitors within 12 weeks before the first day of the run in period.
• The patient suffers from coeliac disease or lactose intolerance.
• Antibiotic treatment within two weeks before the first day of the run in period.
• Patient has any medical, surgical condition that excludes the use of RIC.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Southern Denmark

OTHER

Sponsor Role: collaborator

Aarhus University Hospital

OTHER

Sponsor Role: collaborator

Odense University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Line Elberg Godskesen

Registrar, PhD student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jens Kjeldsen, MD, PhD

Role: STUDY_CHAIR

Odense University Hospital

Line Godskesen

Role: PRINCIPAL_INVESTIGATOR

Odense University Hospital

Locations

Odense University Hospital

Odense, , Denmark

Countries

Denmark

Other Identifiers

S-20140133

Identifier Type: -

Identifier Source: org_study_id