Irritable Bowel SyndromeNCT00957398
Comparing of the Gastrointestinal Motility in Irritable Bowel Syndrome (IBS) Patients With Healthy Volunteers
An observational study of Irritable Bowel Syndrome, run by University of Aarhus at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Irritable Bowel Syndrome
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2009to Apr 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 12 patients with IBS-D and 12 patients with IBS-C who all meet the inclusion criteria.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing of the Gastrointestinal Motility in Irritable Bowel Syndrome (IBS) Patients With Healthy Volunteers Using Magnetic Tracking System (MTS)
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:
Read more
- 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.
Read the 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.
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Irritable Bowel Syndrome, Irritable Bowel Syndrome subgroups, Motility
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| IBS-D | 12 IBS-D patients who will all undergo MTS. | |
| IBS-C | 12 IBS-C patients who will all undergo MTS. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionApr 2012
- Study completionApr 2012
Why it stopped: Not possible to include patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Janne Ladefoged Fassov, University of Aarhus
- Investigators
- Janne Fassov, PhDstudent, Principal investigator, Analfysiologisk Klinik, University Hospital of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00957398
- Sponsor's protocol ID
- 20090009,JLF
- Status last verified
- May 2012
- First submitted
- 11 Aug 2009
- Last updated
- 10 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing of the Gastrointestinal Motility in Irritable Bowel Syndrome (IBS) Patients With Healthy Volunteers Using Magnetic Tracking System (MTS)
- ClinicalTrials.gov ID
- NCT00957398
- Acronym / sponsor ID
- 20090009,JLF
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Irritable Bowel Syndrome, Irritable Bowel Syndrome subgroups, Motility
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Not possible to include patients.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 12 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IBS-D | – | –12 IBS-D patients who will all undergo MTS. |
| IBS-C | – | –12 IBS-C patients who will all undergo MTS. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 12 patients with IBS-D and 12 patients with IBS-C who all meet the inclusion criteria.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Not possible to include patients.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janne Fassov, PhDstudent principal investigator
Analfysiologisk Klinik, University Hospital of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Irritable Bowel Syndrome, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Not possible to include patients.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2012.