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

NCT00957398 | Terminated DMC

• 1 other identifier: 20090009,JLF
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome

Keywords

Irritable Bowel Syndrome; Irritable Bowel Syndrome subgroups; Motility

Study Arms (2)

IBS-D

12 IBS-D patients who will all undergo MTS.

IBS-C

12 IBS-C patients who will all undergo MTS.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Analfysiologisk Klinik, University of Aarhus

Aarhus, Denmark

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Janne Fassov, PhDstudent

  Analfysiologisk Klinik, University Hospital of Aarhus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Study Record Dates

• First Submitted: August 11, 2009
• First Posted: August 12, 2009
• Study Start: August 1, 2009
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: May 10, 2012

Record last verified: 2012-05

Locations

DK (1)