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

University of Aarhus

Status: Unknown

Conditions: Ulcerative Colitis

Treatments: Device: Motilis-3D-transit

Study type: Observational

Funder types: Other

Identifiers

NCT01745029

2012013250

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

20 participants in 1 patient group

Ulcerative Colitis

Treatment:

Device: Motilis-3D-transit