Colitis, UlcerativeNCT02445365
Remote Ischemic Conditioning in Patients With Ulcerative Colitis
A study testing AutoRIC device in people with Colitis, Ulcerative and Gastrointestinal Diseases, run by Odense University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Colitis, Ulcerative, Gastrointestinal Diseases, Pathologic Processes
- What is being tested?
- AutoRIC device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteDenmark
- Study dates
- May 2015to 15 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Remote Ischemic Conditioning (RIC) on Inflammation and Remodelling of Extracellular Matrix Proteins in Patients With Inflammatory Bowel Diseases
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.
Read more
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
- Being tested
- AutoRIC device
- Keywords
- Ulcerative colitis, Remote ischemic conditioning
- Medical subject headings
- Colitis, Ulcerative, Gastrointestinal Diseases, Pathologic Processes, Intestinal Diseases, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AutoRIC deviceDevice
| Study group | Role | What they receive |
|---|---|---|
| Active RIC | Experimental | 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. Receives: Device: AutoRIC device |
| Sham | Sham comparator | As above with a cuff pressure of 20 mmHg Receives: Device: AutoRIC device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in index of clinical activity - numerical change in Mayo score including endoscopic subscore
Measured: 10 days
Secondary outcomes (10)
Change in fecal calprotectin.
Measured: 10 days
Change in endoscopy - central reading according to Mayo endoscopic subscore and UCEIS
Measured: 10 days
Number of patients achieving clinical remission (Mayo score <3)
Measured: 10 days
Patient experience of repeated RIC (questionnaire, including placebo recognition).
Measured: 10 days
Change in histological score of inflammation.
Measured: 10 days
Changes in serum and mucosal cytokine profile in particular Th1/Th2/Th9/Th17/Th22. measured by FlowCytomix Multiplex.
Measured: 10 days
Changes in serum markers of inflammation (serum C-reactive protein).
Measured: 10 days
Changes in serum markers of extracellular matrix proteins (C1M, C3M, C4M, P1NP and VICM).
Measured: 10 days
Changes in serum and mucosal level of CGRP, endothelin-1, endothelin-2.
Measured: 10 days
Effect of RIC in patients with active ulcerative colitis using the Langendorff model (to document activation of a cardioprotective response).
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2015 (estimated)
- Study startMay 2015
- Primary completionFeb 2018
- Study completion15 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colitis, UlcerativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Denmark, Aarhus University Hospital
- Responsible party
- Principal investigator, Line Elberg Godskesen, Odense University Hospital
- Investigators
- Jens Kjeldsen, MD, PhD, Study chair, Odense University HospitalLine Godskesen, Principal investigator, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02445365
- Sponsor's protocol ID
- S-20140133
- Status last verified
- Mar 2018
- First submitted
- 12 May 2015
- Last updated
- 22 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Remote Ischemic Conditioning (RIC) on Inflammation and Remodelling of Extracellular Matrix Proteins in Patients With Inflammatory Bowel Diseases
- ClinicalTrials.gov ID
- NCT02445365
- Acronym / sponsor ID
- S-20140133
- Conditions
- Colitis, Ulcerative, Gastrointestinal Diseases, Pathologic Processes, Intestinal Diseases, Inflammatory Bowel Diseases
- Keywords
- Ulcerative colitis, Remote ischemic conditioning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- University of Southern Denmark, Aarhus University Hospital
- Study start
- May 2015
- Primary completion
- Feb 2018 (actual)
- Study completion
- 15 Feb 2018 (actual)
- First posted
- 15 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active RIC | Experimental | Device: AutoRIC deviceDaily 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 comparator | Device: AutoRIC deviceAs above with a cuff pressure of 20 mmHg |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AutoRIC device | Device | Active RIC, Sham |
Primary outcome
Change in index of clinical activity - numerical change in Mayo score including endoscopic subscore
Time frame: 10 days
10 secondary outcomes
Change in fecal calprotectin.
Time frame: 10 days
Change in endoscopy - central reading according to Mayo endoscopic subscore and UCEIS
Time frame: 10 days
Number of patients achieving clinical remission (Mayo score <3)
Time frame: 10 days
Patient experience of repeated RIC (questionnaire, including placebo recognition).
Time frame: 10 days
Change in histological score of inflammation.
Time frame: 10 days
Changes in serum and mucosal cytokine profile in particular Th1/Th2/Th9/Th17/Th22. measured by FlowCytomix Multiplex.
Time frame: 10 days
Changes in serum markers of inflammation (serum C-reactive protein).
Time frame: 10 days
Changes in serum markers of extracellular matrix proteins (C1M, C3M, C4M, P1NP and VICM).
Time frame: 10 days
Changes in serum and mucosal level of CGRP, endothelin-1, endothelin-2.
Time frame: 10 days
Effect of RIC in patients with active ulcerative colitis using the Langendorff model (to document activation of a cardioprotective response).
Time frame: 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens Kjeldsen, MD, PhD study chair
Odense University Hospital
Line Godskesen principal investigator
Odense University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AutoRIC device in people with Colitis, Ulcerative and Gastrointestinal Diseases, run by Odense University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in index of clinical activity - numerical change in Mayo score including endoscopic subscore (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2018.