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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2014 by University of Aarhus.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01752361
First Posted: December 19, 2012
Last Update Posted: January 7, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Motilis Medica A/S ,Switzerland
Information provided by (Responsible Party):
University of Aarhus
  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 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.


Condition Intervention
Ulcerative Colitis Device: Motilis-3D transit

Study Type: Observational
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

Resource links provided by NLM:


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 healthy volunteers. [ Time Frame: Three days from baseline visit ]

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 healthy volunteers. [ Time Frame: Three days from baseline ]

Other Outcome Measures:
  • 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01752361


Contacts
Contact: AnneMette Haase, Ph.d Student +45 6165 8483 annemette.haase@au.ki.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
Investigators
Principal Investigator: AnneMette Haase, Ph.d Student Aarhus University Hospital
  More Information

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01752361     History of Changes
Other Study ID Numbers: M-20110276
First Submitted: November 27, 2012
First Posted: December 19, 2012
Last Update Posted: January 7, 2014
Last Verified: January 2014

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

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