Ignite Creation Date:
2025-12-25 @ 3:07 AM
Ignite Modification Date:
2025-12-26 @ 1:47 AM
Study NCT ID:
NCT03760133
Status:
COMPLETED
Last Update Posted:
2020-02-20
First Post:
2018-11-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Change of Gut Microbiota After Bowel Preparation and the Effect of Probiotics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-18', 'studyFirstSubmitDate': '2018-11-25', 'studyFirstSubmitQcDate': '2018-11-28', 'lastUpdatePostDateStruct': {'date': '2020-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The effect of probiotics on the change of gut microbiota after bowel preparation.', 'timeFrame': 'eight months', 'description': 'Analysis the change of gut microbiota before and after bowel preparation for colonoscopy, and the effect of probiotics.'}], 'secondaryOutcomes': [{'measure': 'The occurrence of symptoms', 'timeFrame': 'eight months', 'description': 'Analysis the occurrence of symptoms including abdominal discomfort, diarrhea, constipation or abdominal blotting after bowel preparation for colonoscopy.'}, {'measure': 'The correlation between symptoms and gut microbiota..', 'timeFrame': 'eight months', 'description': 'Analysis the the correlation between the symptoms after bowel preparation for colonoscopy and the changes of gut microbiota.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gut microbiota', 'Colonoscopy', 'Bowel preparation', 'Probiotics'], 'conditions': ['Gut Microbiota', 'Bowel Preparation', 'Colonoscopy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the relationship between the change of intestinal bacterial flora and the recovery, and the incidence of symptoms such as abdominal discomfort after colonoscopy. And the investigators will also analyze the effects of probiotics on the degree of change, recovery, and symptom development in intestinal flora.', 'detailedDescription': 'The investigators divided two groups. (total number = 100 subjects)\n\n1. with probiotics group - 50 subjects\n\n * Participants included in this group will be taken probiotics for 1 month after bowel preparation for colonoscopy.\n2. without probiotics group - 50 subjects\n\n * Participants included in this group will not be taken probiotics for 1 month after bowel preparation for colonoscopy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adults between the age of 30 and 70\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': 'NCT03760133', 'briefTitle': 'The Change of Gut Microbiota After Bowel Preparation and the Effect of Probiotics', 'organization': {'class': 'OTHER', 'fullName': 'Kosin University Gospel Hospital'}, 'officialTitle': 'The Change of Gut Microbiota After Bowel Preparation and the Effect of Probiotics: Randomized Controlled, Open-label Trial', 'orgStudyIdInfo': {'id': '2018-07-024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'with Probiotics', 'description': 'Participants included in this group will be taken probiotics for 1 month after bowel preparation for colonoscopy.', 'interventionNames': ['Drug: Duolac']}, {'type': 'NO_INTERVENTION', 'label': 'without Probiotics', 'description': 'Participants included in this group will not be taken probiotics for 1 month after bowel preparation for colonoscopy.'}], 'interventions': [{'name': 'Duolac', 'type': 'DRUG', 'description': 'Participants included in this group will be taken probiotics for 1 month after bowel preparation for colonoscopy.', 'armGroupLabels': ['with Probiotics']}]}, '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': 'The investigators have no plan to share IPD to other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kosin University Gospel Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cell Biotech Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Jae Hyun Kim', 'investigatorAffiliation': 'Kosin University Gospel Hospital'}}}}