search
Back to results

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

Primary Purpose

Irritable Bowel Syndrome

Status
Terminated
Phase
Locations
Denmark
Study Type
Observational
Intervention
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an observational trial for Irritable Bowel Syndrome focused on measuring Irritable Bowel Syndrome, Irritable Bowel Syndrome subgroups, Motility

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Analfysiologisk Klinik, University of Aarhus

Arms of the Study

Arm 1

Arm 2

Arm Type

Arm Label

IBS-D

IBS-C

Arm Description

12 IBS-D patients who will all undergo MTS.

12 IBS-C patients who will all undergo MTS.

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 11, 2009
Last Updated
May 9, 2012
Sponsor
University of Aarhus
search

1. Study Identification

Unique Protocol Identification Number
NCT00957398
Brief Title
Comparing of the Gastrointestinal Motility in Irritable Bowel Syndrome (IBS) Patients With Healthy Volunteers
Official Title
Comparing of the Gastrointestinal Motility in Irritable Bowel Syndrome (IBS) Patients With Healthy Volunteers Using Magnetic Tracking System (MTS)
Study Type
Observational

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Terminated
Why Stopped
Not possible to include patients.
Study Start Date
August 2009 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Aarhus

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
Irritable Bowel Syndrome, Irritable Bowel Syndrome subgroups, Motility

7. Study Design

Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IBS-D
Arm Description
12 IBS-D patients who will all undergo MTS.
Arm Title
IBS-C
Arm Description
12 IBS-C patients who will all undergo MTS.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Study Population Description
12 patients with IBS-D and 12 patients with IBS-C who all meet the inclusion criteria.
Sampling Method
Non-Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janne Fassov, PhDstudent
Organizational Affiliation
Analfysiologisk Klinik, University Hospital of Aarhus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Analfysiologisk Klinik, University of Aarhus
City
Aarhus
Country
Denmark

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs