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

This study has been terminated.
(Not possible to include patients.)
Sponsor:
Information provided by (Responsible Party):
Janne Ladefoged Fassov, University of Aarhus
ClinicalTrials.gov Identifier:
NCT00957398
First received: August 11, 2009
Last updated: May 9, 2012
Last verified: May 2012
  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)

Further study details as provided by University of Aarhus:

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
Study Population

12 patients with IBS-D and 12 patients with IBS-C who all meet the inclusion criteria.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00957398

Locations
Denmark
Analfysiologisk Klinik, University of Aarhus
Aarhus, Denmark
Sponsors and Collaborators
University of Aarhus
Investigators
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 July 28, 2014