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

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01745029
• Other study ID #: 2012013250
• Status: Recruiting
• Phase: N/A
• First received: December 6, 2012
• Last updated: January 6, 2014
• Start date: April 2013
• Est. completion date: March 2015

Study information

• Verified date: January 2014
• Source: University of Aarhus
• Contact: AnneMette Haase, ph.d student
• Phone: +45 61658483
• Email: annemette.haase[@]ki.au.dk
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 2015
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Device:
• Motilis-3D-transit

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital, Department of Hepato and Gastroenterolegy	Aarhus C

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Motilis Medica A/S ,Switzerland

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	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	No
Secondary	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	No