Comparing of the Gastrointestinal Motility in Irritable Bowel Syndrome (IBS) Patients With Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00957398
Recruitment Status : Terminated (Not possible to include patients.)
First Posted : August 12, 2009
Last Update Posted : May 10, 2012
Information provided by (Responsible Party):
Janne Ladefoged Fassov, University of Aarhus

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. 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

Detailed Description:
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.

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.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
12 patients with IBS-D and 12 patients with IBS-C who all meet the inclusion criteria.

Inclusion Criteria:

  • Patients aged over 18.
  • Patients who are diagnosed with IBS according to the Rome III criteria.
  • A total symptom score in GSRS-IBS at a minimum of 40 points.
  • Patients who are psychologically stable and suitable for observation and able to provide informed consent.

Exclusion Criteria:

  • Overt bowel diseases including inflammatory bowel disease.
  • Pregnant or breast feeding.
  • Patients who are considered unable to follow the planned programme of the study, including mental illness or physiological instability.
  • Patients who are on medication with known influence on gastrointestinal motility including those for thyroid disease, diabetes mellitus, celiac disease and neurological disease.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00957398

Analfysiologisk Klinik, University of Aarhus
Aarhus, Denmark
Sponsors and Collaborators
University of Aarhus
Principal Investigator: Janne Fassov, PhDstudent Analfysiologisk Klinik, University Hospital of Aarhus

Responsible Party: Janne Ladefoged Fassov, PhD student, University of Aarhus Identifier: NCT00957398     History of Changes
Other Study ID Numbers: 20090009,JLF
First Posted: August 12, 2009    Key Record Dates
Last Update Posted: May 10, 2012
Last Verified: May 2012

Keywords provided by Janne Ladefoged Fassov, University of Aarhus:
Irritable Bowel Syndrome
Irritable Bowel Syndrome subgroups

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases