Irritable Bowel SyndromeNCT02179905
Brain Imaging, Heart Rate Variability and Serum Fatty Acid in Subjects With Irritable Bowel Syndrome
An observational study of Irritable Bowel Syndrome, run by Shin Kong Wu Ho-Su Memorial Hospital at 1 site in Taiwan.
Trial summary
This study is to analyze the relationship between brain structure, the heart rate variability and the serum fatty acid component of the irritable bowel syndrome patients. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome
- How many people
- 69 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2013to Sep 2013
- 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 20 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Irritable bowel syndrome patients, Control
Who may be able to join
- female
- between 20 and 50 years old
- meet Rome III criteria
Who cannot join
- colon and small intestinal disease
- psychiatric disease patients
- patients received major surgery in the past 5 years
- diabetic patients
- patients with metal implant
Trial locations and contacts
1 site in 1 country.
About this study
This study is to analyze the relationship between brain structure, the heart rate variability and the serum fatty acid component of the irritable bowel syndrome patients.
Read the detailed description
Several studies showed that the gray matter and white matter of the brain related to the symptoms of irritable bowel syndrome patients.
The investigators study is to analyse the relationship between thickness of cortex of irritable patients, the sympathetic tone and the serum fatty acid component of the irritable bowel syndrome patients. It is to clarify the mechanism of irritable bowel syndrome, whether the symptoms of irritable bowel syndrome are related to the thickness of cortex or inflammation status of the body.
- Conditions
- Irritable Bowel Syndrome
- Keywords
- MRI, Heart rate variability, Fatty acid
- 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 |
|---|---|---|
| Irritable bowel syndrome, Control | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The relationship between brain structure, heart rate variability and fatty acid of the irritable bowel syndrome patients.
Measured: Patients who suffered from IBS for more than 5 years.
Secondary outcomes (1)
The relationship between thickness of brain cortex and the symptoms of irritable bowel syndrome
Measured: Patients who suffered from IBS for more than 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2014 (estimated)
- Study startJan 2013
- Primary completionSep 2013
- Study completionSep 2013
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.
- 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
- Observational model
- Case-control
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shin Kong Wu Ho-Su Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02179905
- Sponsor's protocol ID
- SKH-8302-102-DR-14
- Status last verified
- Jun 2014
- First submitted
- 4 Jun 2014
- Last updated
- 2 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Imaging, Heart Rate Variability and Serum Fatty Acid in Subjects With Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT02179905
- Acronym / sponsor ID
- SKH-8302-102-DR-14
- Conditions
- Irritable Bowel Syndrome
- Keywords
- MRI, Heart rate variability, Fatty acid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Shin Kong Wu Ho-Su Memorial HospitalUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 2 Jul 2014 (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.
This study is to analyze the relationship between brain structure, the heart rate variability and the serum fatty acid component of the irritable bowel syndrome patients.
Detailed description
Several studies showed that the gray matter and white matter of the brain related to the symptoms of irritable bowel syndrome patients.
The investigators study is to analyse the relationship between thickness of cortex of irritable patients, the sympathetic tone and the serum fatty acid component of the irritable bowel syndrome patients. It is to clarify the mechanism of irritable bowel syndrome, whether the symptoms of irritable bowel syndrome are related to the thickness of cortex or inflammation status of the body.
Study design
- Observational model
- Case-control
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Irritable bowel syndrome, Control | – | – |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Irritable bowel syndrome patients, Control
Key inclusion criteria (3 listed)
- female
- between 20 and 50 years old
- meet Rome III criteria
Key exclusion criteria (5 listed)
- colon and small intestinal disease
- psychiatric disease patients
- patients received major surgery in the past 5 years
- diabetic patients
- patients with metal implant
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
The relationship between brain structure, heart rate variability and fatty acid of the irritable bowel syndrome patients.
Time frame: Patients who suffered from IBS for more than 5 years.
1 secondary outcome
The relationship between thickness of brain cortex and the symptoms of irritable bowel syndrome
Time frame: Patients who suffered from IBS for more than 5 years.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Shin Kong Wu Ho-Su Memorial Hospital at 1 site in Taiwan.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 2 Jul 2014. 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 Taiwan. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
The relationship between brain structure, heart rate variability and fatty acid of the irritable bowel syndrome patients. (time frame: Patients who suffered from IBS for more than 5 years.). It is what the study was designed to measure, not a finding.
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 2 Jul 2014.