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

NCT01752361 | Unknown DMC

• 1 other identifier: M-20110276
• 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 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.

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 healthy volunteers.

  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 healthy volunteers.

  Three days from baseline

Other Outcomes (1)

• Velocity of progression through the small intestine in severe UC compared to velocity of progression through the small intestine 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

Study Officials

• AnneMette Haase, Ph.d Student

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

AnneMette Haase, Ph.d Student

CONTACT

+45 6165 8483; annemette.haase@au.ki.dk

Klaus Krogh, Professor

CONTACT

+45 2338 5937; klaukrog@rm.dk

Study Design

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

Study Record Dates

• First Submitted: November 27, 2012
• First Posted: December 19, 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)