Brain Imaging, Heart Rate Variability and Serum Fatty Aci... | NCT02179905

Studies
Brain Imaging, Heart Rate Variability and Serum Fatty Acid in Subjects With Irritable Bowel Syndrome

NCT02179905

Sponsor

Shin Kong Wu Ho-Su Memorial Hospital

Status

Completed

Last Update Posted

Jul 2, 2014Estimated

Enrollment

69Actual

Phase

Not provided

Conditions

Irritable Bowel Syndrome

Interventions

Not provided

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Sep 2013Actual

Completion Date

Sep 2013Actual

First Submitted Date

Jun 4, 2014

First Submission Date that Met QC Criteria

Jul 1, 2014

First Posted Date

Jul 2, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 1, 2014

Last Update Posted Date

Jul 2, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

69Actual

Label	Type	Description	Intervention Names
Irritable bowel syndrome, Control

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The relationship between brain structure, heart rate variability and fatty acid of the irritable bowel syndrome patients.		Patients who suffered from IBS for more than 5 years.

Secondary Outcomes

Measure	Description	Time Frame
The relationship between thickness of brain cortex and the symptoms of irritable bowel syndrome		Patients who suffered from IBS for more than 5 years.

Other Outcomes

Measure	Description	Time Frame
The relationship between heart rate variability and symptoms of irritable bowel syndrome patients.		Patients who suffered from IBS for more than 5 years.
The relationship between component of fatty acid and symptoms of irritable bowel syndrome patients.		Patients who suffered from IBS for more than 5 years.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

female
between 20 and 50 years old
meet Rome III criteria

Exclusion Criteria:

colon and small intestinal disease
psychiatric disease patients
patients received major surgery in the past 5 years
diabetic patients
patients with metal implant

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Irritable bowel syndrome patients, Control

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shin Kong Wu Ho-Su Memorial Hospital		Taipei		111	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D043183	Irritable Bowel Syndrome

Ancestor Terms

ID	Term
D003109	Colonic Diseases, Functional
D003108	Colonic Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided