Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2026-06-17 @ 7:34 PM
Study NCT ID:
NCT03153059
Status:
COMPLETED
Last Update Posted:
2017-12-04
First Post:
2017-05-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gut Microbiota and Stool Frequency
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'We will collect the stool from participants, and extract DNA from stool sample. We plan to acquire the Human Derivative Research Description.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2017-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-01', 'studyFirstSubmitDate': '2017-05-11', 'studyFirstSubmitQcDate': '2017-05-11', 'lastUpdatePostDateStruct': {'date': '2017-12-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'stool frequency and gut microbiota', 'timeFrame': 'six months', 'description': 'Analysis of correlation between stool frequency and gut microbiota'}], 'secondaryOutcomes': [{'measure': 'stool consistency and gut microbiota', 'timeFrame': 'six months', 'description': 'Analysis of correlation between stool consistency and gut microbiota'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['gut microbiota', 'stool frequency'], 'conditions': ['Gut Microbiota']}, 'descriptionModule': {'briefSummary': 'We hypothesized that some difference in the composition and distribution of gut microbiota in people with a large number of defecation (two or three times a day or more), people with normal defecation (one time a day or two days), and people with a small number of defecation (two times a week or less).\n\nAnd we investigate the association between gut microbiota and stool frequency.', 'detailedDescription': 'We divided three groups. (total number = 60 subjects)\n\n1. a large number of defecation group (≥ 2-3 times/day) - 20 subjects\n2. normal defecation group (1 time/day or 1 time/2 days) - 20 subjects\n3. a small number of defecation group (≤ 2 times/week) - 20 subjects\n\nAfter collection of stools, we will analyze the composition and distribution of gut microbiota, and compared the results of three groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy volunteers', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adults between the age of 20 and 50\n\nExclusion Criteria:\n\n* subjects with cancer or IBD (inflammatory bowel disease)\n* subjects with history of abdominal surgery\n* subjects who take medication related to gastrointestinal motility within 3 months\n* subjects who take antibiotics within 3 months'}, 'identificationModule': {'nctId': 'NCT03153059', 'briefTitle': 'Gut Microbiota and Stool Frequency', 'organization': {'class': 'OTHER', 'fullName': 'Kosin University Gospel Hospital'}, 'officialTitle': 'The Association Between Gut Microbiota and Stool Frequency', 'orgStudyIdInfo': {'id': '2017-02-017-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'group 1', 'description': 'a large number of defecation group (≥ 2-3 times/day) - 20 subjects', 'interventionNames': ['Other: Stool frequency']}, {'label': 'group 2', 'description': 'normal defecation group (1 time/day or 1 time/2 days) - 20 subjects', 'interventionNames': ['Other: Stool frequency']}, {'label': 'group 3', 'description': 'a small number of defecation group (≤ 2 times/week) - 20 subjects', 'interventionNames': ['Other: Stool frequency']}], 'interventions': [{'name': 'Stool frequency', 'type': 'OTHER', 'description': 'This study is just observational study.', 'armGroupLabels': ['group 1', 'group 2', 'group 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49267', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Kosin University Gospel Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'We have no plan to share IPD to other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kosin University Gospel Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'The association between gut microbiota and stool frequency', 'investigatorFullName': 'Jae Hyun Kim', 'investigatorAffiliation': 'Kosin University Gospel Hospital'}}}}