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

NCT01745029 | Unknown DMC

• 1 other identifier: 2012013250
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcerative Colitis

Keywords

Gastrointestinal Motility; Inflammatory Bowel Disease; Transit time

Outcome Measures

Primary Outcomes (1)

• 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.

  Three days from baseline visit

Secondary Outcomes (1)

• 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.

  Three days from baseline

Other Outcomes (1)

• Velocity of progression through the colonic segments in quiescent UC compared to the velocity of progression in the corresponding colonic segments in healthy volunteers.

  three days from baseline visit

Study Arms (1)

Ulcerative Colitis

Device: Motilis-3D-transit

Interventions

Motilis-3D-transit DEVICE

Ulcerative Colitis

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients suffering from severe Ulcerative Colitis

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead
• Motilis Medica A/S ,Switzerland: collaborator

Study Sites (1)

Aarhus University Hospital, Department of Hepato and Gastroenterolegy

Aarhus C, 8000, Denmark

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Central Study Contacts

AnneMette Haase, ph.d student

CONTACT

+45 61658483; annemette.haase@ki.au.dk

Klaus Krogh, Professor

CONTACT

+45 2338 5937; klaukrog@rm.dk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2012
• First Posted: December 7, 2012
• Study Start: April 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: March 1, 2015
• Last Updated: January 7, 2014

Record last verified: 2014-01

Locations

DK (1)