Clinical Trial: Comparing of the Gastrointestinal Motility in Irritable Bowel Syndrome (IBS) Patients With Healthy Volunteers
Study Status: Terminated
Recruit Status: Terminated
Study Type: Observational
Official Title: Comparing of the Gastrointestinal Motility in Irritable Bowel Syndrome (IBS) Patients With Healthy Volunteers Using Magnetic Tracking System (MTS)
Brief Summary:
The hypothesis of the study is that the motility of the small intestine and the colon will alter according to the subtype of the irritable bowel syndrome (IBS) patient.
IBS is currently classified into following subtypes:
- Diarrhoea-IBS (IBS-D)
- Constipation-IBS (IBS-C)
- Mixed-IBS (IBS-M)
- Unsubtyped-IBS (IBS-U)
according to the Bristol scale.
Magnetic Tracking System (MTS) is a new minimal invasive technic that allows motility studies of the whole human gastrointestinal tract.
The magnetic cylindrical pill (6x15mm) is swallowed at 9 AM on day one. The recording is made until 4 PM and again from 8 AM until 2 PM on day two. The patient is placed in a bed and will be supplied with standardized food and fluid.
The Magnetic Tracking System consists of a 4 x 4 matrix of sensors positioned with respect to the anatomical reference points. Before measurements, the matrix is calibrated by offsetting the earth's and environmental magnetic fields. During the experiment, the magnet coordinates are continuously monitored and transmitted to a computer for processing and storage. Respiratory artifacts will be filtered out. Digestive movements will then be classified as 1) non-propulsive or 2) propulsive and transformed into either trajectory or dynamic graphs of the digestive motility.
The Magnetic Tracking System has the advantage from both radiographic and scintigraphic methods of conducting the tests without any radiation exposure to the patient. Preli
Detailed Summary: A MTS study on healthy volunteers is all ready done under the same conditions as described abow in Denmark. This study has projectID 20080037 and is approved by the Danish Dataprotection Agency as well as The Regional Committee on Biomedical Research Ethics.
Sponsor: University of Aarhus
Current Primary Outcome:
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: University of Aarhus
Dates:
Date Received: August 11, 2009
Date Started: August 2009
Date Completion:
Last Updated: May 9, 2012
Last Verified: May 2012
