Gastrointestinal Transit Times and Motility in Severe Ulcerative Colitis Obtained by Motilis-3D-transit
Recruitment status was Recruiting
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
|Official Title:||Gastrointestinal Transit Times and Motility in Patients Suffering From Severe Ulcerative Colitis Obtained by Motilis-3D-transit|
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Velocity of progression through the small intestine in severe UC compared to velocity of progression through the small intestine in healthy volunteers. [ Time Frame: three days from baseline visit ] [ Designated as safety issue: No ]
|Study Start Date:||April 2013|
|Estimated Study Completion Date:||March 2015|
|Estimated Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01752361
|Contact: AnneMette Haase, Ph.d Student||+45 6165 firstname.lastname@example.org|
|Contact: Klaus Krogh, Professor||+45 2338 email@example.com|
|Aarhus University Hospital, Department of Hepato and Gastroenterolegy||Recruiting|
|Aarhus C, Denmark, 8000|
|Contact: AnneMette Haase, Ph.d Student +45 6165 8483 firstname.lastname@example.org|
|Principal Investigator: AnneMette Haase, Ph.d Student|
|Principal Investigator:||AnneMette Haase, Ph.d Student||Aarhus University Hospital|