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

• Conditions: Ulcerative Colitis
• Interventions: Device: Motilis-3D transit

• Registration Number: NCT01752361
• Lead Sponsor: University of Aarhus

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2012-11-27
• Study First Submitted QC: 2012-12-14
• Study First Posted: 2012-12-19
• Study Start: 2013-04
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-06
• Last Update Posted: 2014-01-07
• Primary Completion: 2014-04
• Study Completion: 2015-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ulcerative Colitis	Motilis-3D transit	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Aarhus University Hospital, Department of Hepato and Gastroenterolegy; 🇩🇰 Aarhus C, Denmark