Gastrointestinal Transit Times and Motility in Severe Ulcerative Colitis Obtained by Motilis-3D-transit

This study is currently recruiting participants.
Verified January 2014 by University of Aarhus
Sponsor:
Collaborator:
Motilis Medica A/S ,Switzerland
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01752361
First received: November 27, 2012
Last updated: January 6, 2014
Last verified: January 2014

November 27, 2012
January 6, 2014
April 2013
April 2014   (final data collection date for 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01752361 on ClinicalTrials.gov Archive Site
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 ]
Same as current
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 ]
Same as current
 
Gastrointestinal Transit Times and Motility in Severe Ulcerative Colitis Obtained by Motilis-3D-transit
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.

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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients suffering from severe Ulcerative Colitis

Ulcerative Colitis
Device: Motilis-3D transit
Ulcerative Colitis
Intervention: Device: Motilis-3D transit
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
March 2015
April 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact: AnneMette Haase, Ph.d Student +45 6165 8483 annemette.haase@au.ki.dk
Contact: Klaus Krogh, Professor +45 2338 5937 klaukrog@rm.dk
Denmark
 
NCT01752361
M-20110276
Yes
University of Aarhus
University of Aarhus
Motilis Medica A/S ,Switzerland
Principal Investigator: AnneMette Haase, Ph.d Student Aarhus University Hospital
University of Aarhus
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP