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

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01752361
• Other study ID #: M-20110276
• Status: Recruiting
• Phase: N/A
• First received: November 27, 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 6165 8483
• Email: annemette.haase[@]au.ki.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 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.

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 Control, 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 small intestine in severe UC compared to velocity of progression through the small intestine 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 healthy volunteers.		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 healthy volunteers.		Three days from baseline	No