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Remote Ischemic Conditioning in Patients With Ulcerative Colitis

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ClinicalTrials.gov Identifier: NCT02445365
Recruitment Status : Recruiting
First Posted : May 15, 2015
Last Update Posted : November 7, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment
Colitis, Ulcerative Gastrointestinal Diseases Pathologic Processes Intestinal Diseases Inflammatory Bowel Diseases Device: AutoRIC device

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Effect of Remote Ischemic Conditioning (RIC) on Inflammation and Remodelling of Extracellular Matrix Proteins in Patients With Inflammatory Bowel Diseases
Study Start Date : May 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 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.
Device: AutoRIC device
Sham Comparator: Sham
As above with a cuff pressure of 20 mmHg
Device: AutoRIC device


Outcome Measures

Primary Outcome Measures :
  1. Change in index of clinical activity - numerical change in Mayo score including endoscopic subscore [ Time Frame: 10 days ]

Secondary Outcome Measures :
  1. Change in fecal calprotectin. [ Time Frame: 10 days ]
  2. Change in endoscopy - central reading according to Mayo endoscopic subscore and UCEIS [ Time Frame: 10 days ]
  3. Number of patients achieving clinical remission (Mayo score <3) [ Time Frame: 10 days ]
  4. Patient experience of repeated RIC (questionnaire, including placebo recognition). [ Time Frame: 10 days ]
  5. Change in histological score of inflammation. [ Time Frame: 10 days ]
  6. Changes in serum and mucosal cytokine profile in particular Th1/Th2/Th9/Th17/Th22. measured by FlowCytomix Multiplex. [ Time Frame: 10 days ]
  7. Changes in serum markers of inflammation (serum C-reactive protein). [ Time Frame: 10 days ]
  8. Changes in serum markers of extracellular matrix proteins (C1M, C3M, C4M, P1NP and VICM). [ Time Frame: 10 days ]
  9. Changes in serum and mucosal level of CGRP, endothelin-1, endothelin-2. [ Time Frame: 10 days ]
  10. Effect of RIC in patients with active ulcerative colitis using the Langendorff model (to document activation of a cardioprotective response). [ Time Frame: 10 days ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02445365


Contacts
Contact: Line Godskesen, MD + 45 65 41 27 57 line.elberg.godskesen@rsyd.dk
Contact: Jens Kjeldsen, MD, PhD + 45 65 41 27 65 jens.kjeldsen@rsyd.dk

Locations
Denmark
Odense University Hospital Recruiting
Odense, Denmark, 5000
Contact: Line Godskesen, MD    + 45 24 80 81 09    line.elberg.godskesen@rsyd.dk   
Sponsors and Collaborators
Odense University Hospital
University of Southern Denmark
Aarhus University Hospital
Investigators
Study Chair: Jens Kjeldsen, MD, PhD Odense University Hospital
Principal Investigator: Line Godskesen Odense University Hospital
More Information

Responsible Party: Line Elberg Godskesen, Registrar, PhD student, Odense University Hospital
ClinicalTrials.gov Identifier: NCT02445365     History of Changes
Other Study ID Numbers: S-20140133
First Posted: May 15, 2015    Key Record Dates
Last Update Posted: November 7, 2017
Last Verified: November 2017

Keywords provided by Line Elberg Godskesen, Odense University Hospital:
Ulcerative colitis
Remote ischemic conditioning

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pathologic Processes
Gastroenteritis
Colonic Diseases