Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2026-01-01 @ 3:12 AM
Study NCT ID:
NCT02179905
Status:
COMPLETED
Last Update Posted:
2014-07-02
First Post:
2014-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Brain Imaging, Heart Rate Variability and Serum Fatty Acid in Subjects With Irritable Bowel Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D043183', 'term': 'Irritable Bowel Syndrome'}], 'ancestors': [{'id': 'D003109', 'term': 'Colonic Diseases, Functional'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 69}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-01', 'studyFirstSubmitDate': '2014-06-04', 'studyFirstSubmitQcDate': '2014-07-01', 'lastUpdatePostDateStruct': {'date': '2014-07-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The relationship between heart rate variability and symptoms of irritable bowel syndrome patients.', 'timeFrame': 'Patients who suffered from IBS for more than 5 years.'}, {'measure': 'The relationship between component of fatty acid and symptoms of irritable bowel syndrome patients.', 'timeFrame': 'Patients who suffered from IBS for more than 5 years.'}], 'primaryOutcomes': [{'measure': 'The relationship between brain structure, heart rate variability and fatty acid of the irritable bowel syndrome patients.', 'timeFrame': 'Patients who suffered from IBS for more than 5 years.'}], 'secondaryOutcomes': [{'measure': 'The relationship between thickness of brain cortex and the symptoms of irritable bowel syndrome', 'timeFrame': 'Patients who suffered from IBS for more than 5 years.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['MRI', 'Heart rate variability', 'Fatty acid'], 'conditions': ['Irritable Bowel Syndrome']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Several studies showed that the gray matter and white matter of the brain related to the symptoms of irritable bowel syndrome patients.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Irritable bowel syndrome patients, Control', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* female\n* between 20 and 50 years old\n* meet Rome III criteria\n\nExclusion Criteria:\n\n* colon and small intestinal disease\n* psychiatric disease patients\n* patients received major surgery in the past 5 years\n* diabetic patients\n* patients with metal implant'}, 'identificationModule': {'nctId': 'NCT02179905', 'briefTitle': 'Brain Imaging, Heart Rate Variability and Serum Fatty Acid in Subjects With Irritable Bowel Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Shin Kong Wu Ho-Su Memorial Hospital'}, 'officialTitle': 'Brain Imaging, Heart Rate Variability and Serum Fatty Acid in Subjects With Irritable Bowel Syndrome', 'orgStudyIdInfo': {'id': 'SKH-8302-102-DR-14'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Irritable bowel syndrome, Control'}]}, 'contactsLocationsModule': {'locations': [{'zip': '111', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Shin Kong Wu Ho-Su Memorial Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shin Kong Wu Ho-Su Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}