Comparing of the Gastrointestinal Motility in Irritable Bowel Syndrome (IBS) Patients With Healthy Volunteers
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Purpose
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 |
|---|
|
Irritable Bowel Syndrome |
| Study Type: | Observational |
| Official Title: | Comparing of the Gastrointestinal Motility in Irritable Bowel Syndrome (IBS) Patients With Healthy Volunteers Using Magnetic Tracking System (MTS) |
| Enrollment: | 10 |
| Study Start Date: | August 2009 |
| Study Completion Date: | April 2012 |
| Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
IBS-D
12 IBS-D patients who will all undergo MTS.
|
|
IBS-C
12 IBS-C patients who will all undergo MTS.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
Contacts and Locations| Denmark | |
| Analfysiologisk Klinik, University of Aarhus | |
| Aarhus, Denmark | |
| Principal Investigator: | Janne Fassov, PhDstudent | Analfysiologisk Klinik, University Hospital of Aarhus |
More Information
No publications provided
| Responsible Party: | Janne Ladefoged Fassov, PhD student, University of Aarhus |
| ClinicalTrials.gov Identifier: | NCT00957398 History of Changes |
| Other Study ID Numbers: | 20090009,JLF |
| Study First Received: | August 11, 2009 |
| Last Updated: | May 9, 2012 |
| Health Authority: | Denmark: Danish Dataprotection Agency Denmark: The Regional Committee on Biomedical Research Ethics |
Keywords provided by University of Aarhus:
|
Irritable Bowel Syndrome Irritable Bowel Syndrome subgroups Motility |
Additional relevant MeSH terms:
|
Irritable Bowel Syndrome Colonic Diseases, Functional Colonic Diseases |
Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013