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

January 6, 2014 updated by: University of Aarhus

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus C, Denmark, 8000
        • Recruiting
        • Aarhus University Hospital, Department of Hepato and Gastroenterolegy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients suffering from severe Ulcerative Colitis

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Ulcerative Colitis
Device: Motilis-3D transit

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: Three days from baseline visit
Three days from baseline visit

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: Three days from baseline
Three days from baseline

Other Outcome Measures

Outcome Measure
Time Frame
Velocity of progression through the small intestine in severe UC compared to velocity of progression through the small intestine in healthy volunteers.
Time Frame: three days from baseline visit
three days from baseline visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Motilis Medica A/S ,Switzerland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (ANTICIPATED)

April 1, 2014

Study Completion (ANTICIPATED)

March 1, 2015

Study Registration Dates

First Submitted

November 27, 2012

First Submitted That Met QC Criteria

December 14, 2012

First Posted (ESTIMATE)

December 19, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

January 7, 2014

Last Update Submitted That Met QC Criteria

January 6, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M-20110276

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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