Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2026-02-13 @ 9:53 AM
Study NCT ID:
NCT03949257
Status:
UNKNOWN
Last Update Posted:
2019-05-14
First Post:
2019-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dynamic Changes of Gut Microbiota in UC After FMT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069467', 'term': 'Fecal Microbiota Transplantation'}], 'ancestors': [{'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2019-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-05-12', 'studyFirstSubmitDate': '2019-05-12', 'studyFirstSubmitQcDate': '2019-05-12', 'lastUpdatePostDateStruct': {'date': '2019-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'changes of gut microbiota', 'timeFrame': '7 days', 'description': 'gut microbiota will be collected through the colonic TET'}], 'secondaryOutcomes': [{'measure': 'frequency of defecation', 'timeFrame': '7 days', 'description': 'the frequency of defecation in UC patients will be recorded'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['transendoscopic enteral tubing', 'gut microbiota', 'ulcerative colitis'], 'conditions': ['Ulcerative Colitis']}, 'referencesModule': {'references': [{'pmid': '27556065', 'type': 'BACKGROUND', 'citation': 'Peng Z, Xiang J, He Z, Zhang T, Xu L, Cui B, Li P, Huang G, Ji G, Nie Y, Wu K, Fan D, Zhang F. Colonic transendoscopic enteral tubing: A novel way of transplanting fecal microbiota. Endosc Int Open. 2016 Jun;4(6):E610-3. doi: 10.1055/s-0042-105205. Epub 2016 Apr 28.'}, {'pmid': '22228167', 'type': 'BACKGROUND', 'citation': 'Westwood DA, Alexakis N, Connor SJ. Transparent cap-assisted colonoscopy versus standard adult colonoscopy: a systematic review and meta-analysis. Dis Colon Rectum. 2012 Feb;55(2):218-25. doi: 10.1097/DCR.0b013e31823461ef.'}]}, 'descriptionModule': {'briefSummary': 'A prospective study to investigate the dynamic changes of gut microbiota through colonic transendoscopic enteral tubing in patients with ulcerative colitis after fecal microbiota transplantation.', 'detailedDescription': 'Colonic transendoscopic enteral tubing (TET) is a novel, safe, convenient, and reliable way for fecal microbiota transplantation (FMT) and the whole-colon enema treatment. This tube also can serve as a medium for collecting gut microbiota. Fecal Microbiota Transplantation (FMT) was identified to be promising for ulcerative colitis (UC). This study aims to investigate the dynamic changes of gut microbiota in patients with UC after FMT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients were diagnosed with mild or moderate ulcerative colitis.\n* Patients need colonic TET and FMT\n* Must be able to colonic TET and no contraindication by endoscopic examination, consent colon TET implantation and not associated with severe intestinal lesions such as fistula, stenosis, complex perianal lesions, severe ileocecal or ascending colon lesions resulting in no proper site for titanium clip fixation.\n* Age \\> 7 years old and \\< 65 years old\n\nExclusion Criteria:\n\n* gut microbiota was not collected successfully'}, 'identificationModule': {'nctId': 'NCT03949257', 'briefTitle': 'Dynamic Changes of Gut Microbiota in UC After FMT', 'organization': {'class': 'OTHER', 'fullName': 'The Second Hospital of Nanjing Medical University'}, 'officialTitle': 'Dynamic Changes of Gut Microbiota in Patients With Ulcerative Colitis After Fecal Transplantation', 'orgStudyIdInfo': {'id': 'FMT-TET-190507'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'colonic TET and FMT', 'description': 'gut microbiota will be collected through the colonic TET after FMT', 'interventionNames': ['Device: colonic transendoscopic enteral tubing']}], 'interventions': [{'name': 'colonic transendoscopic enteral tubing', 'type': 'DEVICE', 'otherNames': ['fecal microbiota transplantation'], 'description': 'Colonic transendoscopic enteral tubing (TET) is a novel, safe, convenient, and reliable way for fecal microbiota transplantation (FMT) and the whole-colon enema treatment.', 'armGroupLabels': ['colonic TET and FMT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210011', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'faming zhang, MD; PhD', 'role': 'CONTACT', 'email': 'fzhang@njmu.edu.cn', 'phone': '086-25-58509883'}, {'name': 'min dai, MD; PhD', 'role': 'CONTACT', 'email': 'daimin@njmu.edu.cn', 'phone': '086-25-58509884'}], 'overallOfficials': [{'name': 'faming zhang, MD; PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'The Second Hospital of Nanjing Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Second Hospital of Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}