Comparing of the Gastrointestinal Motility in Irritable Bowel Syndrome (IBS) Patients With Healthy Volunteers
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|ClinicalTrials.gov Identifier: NCT00957398|
Recruitment Status : Terminated (Not possible to include patients.)
First Posted : August 12, 2009
Last Update Posted : May 10, 2012
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. Preliminary studies have shown good concordance between the transit measured with the magnet and radiographic transit times.
The investigators wish to use this method, MTS, to compare the motility of the small intestine and the colon in patients with IBS-D and IBS-C as well as to compare these to groups to MTS done on healthy volunteers under the same conditions as the IBS patients.
|Condition or disease|
|Irritable Bowel Syndrome|
|Study Type :||Observational|
|Actual Enrollment :||10 participants|
|Official Title:||Comparing of the Gastrointestinal Motility in Irritable Bowel Syndrome (IBS) Patients With Healthy Volunteers Using Magnetic Tracking System (MTS)|
|Study Start Date :||August 2009|
|Actual Primary Completion Date :||April 2012|
|Actual Study Completion Date :||April 2012|
12 IBS-D patients who will all undergo MTS.
12 IBS-C patients who will all undergo MTS.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00957398
|Analfysiologisk Klinik, University of Aarhus|
|Principal Investigator:||Janne Fassov, PhDstudent||Analfysiologisk Klinik, University Hospital of Aarhus|