Text Size

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

This study is currently recruiting participants.
Verified April 2013 by University of Aarhus
Sponsor:
Collaborator:
Motilis Medica A/S ,Switzerland
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01745029
First received: December 6, 2012
Last updated: April 12, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention
Ulcerative Colitis
 Device: Motilis-3D-transit

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Gastrointestinal Motility in Patients Suffering From Severe Ulcerative Colitis Obtained by Motilis-3D-transit

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • 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. [ Time Frame: Three days from baseline visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: Three days from baseline ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Velocity of progression through the colonic segments in quiescent UC compared to the velocity of progression in the corresponding colonic segments in healthy volunteers. [ Time Frame: three days from baseline visit ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
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)
Groups/Cohorts Assigned Interventions
Ulcerative Colitis Device: Motilis-3D-transit

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients suffering from severe Ulcerative Colitis

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01745029

Contacts
Contact: AnneMette Haase, ph.d student +45 61658483 annemette.haase@ki.au.dk
Contact: Klaus Krogh, Professor +45 2338 5937 klaukrog@rm.dk

Locations
Denmark
Aarhus University Hospital, Department of Hepato and Gastroenterolegy Recruiting
Aarhus C, Denmark, 8000
Contact: AnneMette Haase, Ph.d Student     +45 6165 8483     annemette.haase@ki.au.dk    
Principal Investigator: AnneMette Haase, Ph.d Student            
Sponsors and Collaborators
University of Aarhus
Motilis Medica A/S ,Switzerland
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01745029     History of Changes
Other Study ID Numbers: 2012013250
Study First Received: December 6, 2012
Last Updated: April 12, 2013
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by University of Aarhus:
Gastrointestinal Motility
Inflammatory Bowel Disease
Transit time

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013