Ulcerative ColitisNCT01752361
Gastrointestinal Transit Times and Motility in Severe Ulcerative Colitis Obtained by Motilis-3D-transit
An observational study of Ulcerative Colitis, run by University of Aarhus at 1 site in Denmark.
Trial summary
The purpose of this study is to describe gastrointestinal (GI) motility in patients suffering from severe Ulcerative Colitis (UC) and to compare these results with similar results from a study on healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Motilis-3D transit
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2013to Mar 2015
- Phase
- Observational
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients suffering from severe Ulcerative Colitis
Who may be able to join
- Severe Ulcerative colitis (modified Truelove and Witt score)
- Signed informed consent obtained
- Fasted since midnight
Who cannot join
- Known GI related symptoms complaints or GI diseases
- Swallowing disorders
- Cancer or other life threatening diseases or conditions
- Pregnancy or breast-feeding
- Previous abdominal surgery
- Abdominal diameter >140cm?
Show all 13Show fewer
- Drug abuse or alcoholism
- Irregular bowel movements
- Known cardiovascular or pulmonary diseases
- Participation in any clinical study within the last 30 days
- Cardiac pacemaker or infusion pump or any other implanted or portable electro-mechanical medical device.
- Medication affecting GI motility
- MRI within the next four weeks
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Aarhus University Hospital, Department of Hepato and Gastroenterolegy
Aarhus C, 8000
AnneMette Haase, Ph.d Student, +45 6165 8483, annemette.haase@ki.au.dk
AnneMette Haase, Ph.d Student
About this study
Official title: Gastrointestinal Transit Times and Motility in Patients Suffering From Severe Ulcerative Colitis Obtained by Motilis-3D-transit
The purpose of this study is to describe gastrointestinal (GI) motility in patients suffering from severe Ulcerative Colitis (UC) and to compare these results with similar results from a study on healthy subjects.
Both studies are done with the use of Motilis 3D-Transit system which consists of a small electronic capsule ingested and detected by a receiver carried by the patient. Position and orientation of the capsule are interpreted by dedicated computer software and transit times, progression velocity and contraction frequencies can be revealed.
Read more
The study is mainly descriptive and is designed to test and evaluate the usefulness of the Motilis 3D Transit system in UC patients and to tell us more about GI motility during severe inflammation.
Motilis 3D-Transit system gives us a unique chance to study the gastrointestinal canal as a whole during severe illness.
We expect to include 20 patients suffering from severe UC admitted to Hospital with the purpose of getting medical treatment. We do not expect any drop out, but in case of drop out a new patient will be included.
- Conditions
- Ulcerative Colitis
- Being tested
- Motilis-3D transit
- Keywords
- Gastrointestinal Motility, Inflammatory Bowel Disease, Transit time
- Medical subject headings
- Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motilis-3D transitDevice
| Study group | Role | What they receive |
|---|---|---|
| Ulcerative Colitis | Not described Receives: Device: Motilis-3D transit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Velocity of progression through the inflamed part of the colon in severe UC compared to the velocity of progression in the corresponding colonic segment in healthy volunteers.
Measured: Three days from baseline visit
Secondary outcomes (1)
Velocity of progression through the non-inflamed colonic segments in severe UC compared to the velocity of progression in the corresponding colonic segments in healthy volunteers.
Measured: Three days from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2012 (estimated)
- Study startApr 2013
- Primary completionApr 2014 (estimated)
- Study completionMar 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Motilis Medica A/S ,Switzerland
- Responsible party
- Sponsor
- Investigators
- AnneMette Haase, Ph.d Student, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01752361
- Sponsor's protocol ID
- M-20110276
- Status last verified
- Jan 2014
- First submitted
- 27 Nov 2012
- Last updated
- 7 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastrointestinal Transit Times and Motility in Patients Suffering From Severe Ulcerative Colitis Obtained by Motilis-3D-transit
- ClinicalTrials.gov ID
- NCT01752361
- Acronym / sponsor ID
- M-20110276
- Conditions
- Ulcerative Colitis
- Keywords
- Gastrointestinal Motility, Inflammatory Bowel Disease, Transit time
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Motilis Medica A/S ,Switzerland
- Study start
- Apr 2013
- Primary completion
- Apr 2014 (estimated)
- Study completion
- Mar 2015 (estimated)
- First posted
- 19 Dec 2012 (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.
The purpose of this study is to describe gastrointestinal (GI) motility in patients suffering from severe Ulcerative Colitis (UC) and to compare these results with similar results from a study on healthy subjects.
Both studies are done with the use of Motilis 3D-Transit system which consists of a small electronic capsule ingested and detected by a receiver carried by the patient. Position and orientation of the capsule are interpreted by dedicated computer software and transit times, progression velocity and contraction frequencies can be revealed.
The study is mainly descriptive and is designed to test and evaluate the usefulness of the Motilis 3D Transit system in UC patients and to tell us more about GI motility during severe inflammation.
Motilis 3D-Transit system gives us a unique chance to study the gastrointestinal canal as a whole during severe illness.
We expect to include 20 patients suffering from severe UC admitted to Hospital with the purpose of getting medical treatment. We do not expect any drop out, but in case of drop out a new patient will be included.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ulcerative Colitis | – | Device: Motilis-3D transit |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from severe Ulcerative Colitis
Key inclusion criteria (3 listed)
- Severe Ulcerative colitis (modified Truelove and Witt score)
- Signed informed consent obtained
- Fasted since midnight
Key exclusion criteria (13 listed)
- Known GI related symptoms complaints or GI diseases
- Swallowing disorders
- Cancer or other life threatening diseases or conditions
- Pregnancy or breast-feeding
- Previous abdominal surgery
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 |
|---|---|---|
| Motilis-3D transit | Device | Ulcerative Colitis |
Primary outcome
Velocity of progression through the inflamed part of the colon in severe UC compared to the velocity of progression in the corresponding colonic segment in healthy volunteers.
Time frame: Three days from baseline visit
1 secondary outcome
Velocity of progression through the non-inflamed colonic segments in severe UC compared to the velocity of progression in the corresponding colonic segments in healthy volunteers.
Time frame: Three days from baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2014.
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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.
AnneMette Haase, Ph.d Student principal investigator
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcerative Colitis, run by University of Aarhus 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 3 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 7 Jan 2014. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact AnneMette Haase, Ph.d Student (+45 6165 8483, annemette.haase@au.ki.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Velocity of progression through the inflamed part of the colon in severe UC compared to the velocity of progression in the corresponding colonic segment in healthy volunteers. (time frame: Three days from baseline visit). 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 7 Jan 2014.