Clinical trial NCT01745029: Gastrointestinal Motility in Severe Ulcerative Colitis Obtained by Motilis-3D-transit
Official title: Gastrointestinal Motility in Patients Suffering From Severe Ulcerative Colitis Obtained by Motilis-3D-transit
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ulcerative Colitis
Keywords: Gastrointestinal Motility
Inflammatory Bowel Disease
Transit time
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Motilis Medica A/S ,Switzerland
First posted: 2012-12-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suffering from severe Ulcerative Colitis

Brief 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 obtained in remission.

The study is 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 investigators more about GI motility during and after severe inflammation.

Motilis 3D-Transit system gives investigators a unique chance to study the gastrointestinal canal as a whole during and after severe illness.

The investigators expect to include 20 patients suffering from severe UC admitted to Hospital with the purpose of getting medical treatment. The investigators do not expect any drop out, but in case of drop out a new patient will be included.


Eligibility criteria: Inclusion criteria:

* Severe Ulcerative colitis (modified Truelove and Witt score)
* Signed informed consent obtained
* Fasted since midnight

Exclusion Criteria:

* 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?
* 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

Primary outcomes:
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 quiescent UC.
timeFrame: Three days from baseline visit
Secondary outcomes:
measure: Velocity of progression through the non-inflamed colonic segments in severe UC compared to the velocity of progression in the corresponding colonic segments in quiescent UC.
timeFrame: Three days from baseline
Other outcomes:
measure: Velocity of progression through the colonic segments in quiescent UC compared to the velocity of progression in the corresponding colonic segments in healthy volunteers.
timeFrame: three days from baseline visit
Locations:
city: Aarhus C
country: Denmark
facility: Aarhus University Hospital, Department of Hepato and Gastroenterolegy
Study officials:
References: