Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2026-03-05 @ 11:39 PM
Study NCT ID:
NCT02560727
Status:
UNKNOWN
Last Update Posted:
2015-09-25
First Post:
2015-09-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Evaluate the Feasibility, Safety, and Efficacy of TET for FMT Via Colonic Approach
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020685', 'term': 'Colonoscopes'}], 'ancestors': [{'id': 'D020776', 'term': 'Endoscopes, Gastrointestinal'}, {'id': 'D019723', 'term': 'Endoscopes'}, {'id': 'D019719', 'term': 'Diagnostic Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D013523', 'term': 'Surgical Equipment'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2016-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-09-24', 'studyFirstSubmitDate': '2015-09-21', 'studyFirstSubmitQcDate': '2015-09-24', 'lastUpdatePostDateStruct': {'date': '2015-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Adverse events', 'timeFrame': 'one year', 'description': 'Number of adverse events.'}], 'primaryOutcomes': [{'measure': 'durability of clinical remission', 'timeFrame': 'One year', 'description': 'The durability of clinical remission (days) after Fecal Microbiota Transplantation procedure by TET.Defined as Montreal score S0 (clinical remission)'}], 'secondaryOutcomes': [{'measure': 'Patients with worsened disease', 'timeFrame': 'one year', 'description': 'Number of patients with worsened disease. Increase in Montreal score S1, S2 and S3.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Inflammatory Bowel Diseases', 'Fecal Microbiota Transplantation', 'transendoscopic enteral tubing'], 'conditions': ['Inflammatory Bowel Diseases']}, 'referencesModule': {'references': [{'pmid': '25322359', 'type': 'BACKGROUND', 'citation': 'Youngster I, Russell GH, Pindar C, Ziv-Baran T, Sauk J, Hohmann EL. Oral, capsulized, frozen fecal microbiota transplantation for relapsing Clostridium difficile infection. JAMA. 2014 Nov 5;312(17):1772-8. doi: 10.1001/jama.2014.13875.'}, {'pmid': '23323867', 'type': 'BACKGROUND', 'citation': 'van Nood E, Vrieze A, Nieuwdorp M, Fuentes S, Zoetendal EG, de Vos WM, Visser CE, Kuijper EJ, Bartelsman JF, Tijssen JG, Speelman P, Dijkgraaf MG, Keller JJ. Duodenal infusion of donor feces for recurrent Clostridium difficile. N Engl J Med. 2013 Jan 31;368(5):407-15. doi: 10.1056/NEJMoa1205037. Epub 2013 Jan 16.'}, {'pmid': '25168749', 'type': 'BACKGROUND', 'citation': "Cui B, Feng Q, Wang H, Wang M, Peng Z, Li P, Huang G, Liu Z, Wu P, Fan Z, Ji G, Wang X, Wu K, Fan D, Zhang F. Fecal microbiota transplantation through mid-gut for refractory Crohn's disease: safety, feasibility, and efficacy trial results. J Gastroenterol Hepatol. 2015 Jan;30(1):51-8. doi: 10.1111/jgh.12727."}, {'pmid': '30972640', 'type': 'DERIVED', 'citation': 'Ding X, Li Q, Li P, Zhang T, Cui B, Ji G, Lu X, Zhang F. Long-Term Safety and Efficacy of Fecal Microbiota Transplant in Active Ulcerative Colitis. Drug Saf. 2019 Jul;42(7):869-880. doi: 10.1007/s40264-019-00809-2.'}]}, 'descriptionModule': {'briefSummary': 'No technique by placing a tube through anus into cecum for whole colon administration. This study aimed to evaluate the feasibility, safety, and efficacy of transendoscopic enteral tubing (TET) in fecal microbiota transplantation (FMT) through whole colon.', 'detailedDescription': 'The previous reported fecal microbiota transplantation (FMT)through whole colon. delivering ways were involved with upper digestive tract, middle digestive tract and lower digestive tract. FMT via colonoscope is the most common approach, participants have to endure the discomfortable of bowel preparation and colonoscopy, and FMT by colonoscopy was recommended for repeat FMT treatment in short period. Traditional enema infuses bacteria solution into rectal and sigmoid colon but cannot spread to whole colon.No technique by placing a tube through anus into cecum for whole colon administration, which could be maintained for repeat FMTs.To solve these problems, investigators designed a new technique called transendoscopic enteral tubing (TET).the TET tube was fixed at cecum by clips under endoscopy. This study aimed to evaluate the feasibility, safety, and efficacy of TET for FMT via colonic approach.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '10 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'A prospective study was conducted at the Digestive Medicine Center of the Second Affiliated Hospital of Nanjing Medical University from October 2014 to June 2016. All recruited cases met the including criteria: aged 10-70 yr, suitable for endoscopy, and agreed to undergo FMT and TET', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Mild to moderate ulcerative colitis (Montreal classification)\n\nExclusion Criteria:\n\n* Diagnosed as ulcerative colitis first time.\n* No history of using Biologic, immunomodulatory therapy or corticosteroid therapy.\n* With contraindication of endoscopy.'}, 'identificationModule': {'nctId': 'NCT02560727', 'acronym': 'TET', 'briefTitle': 'To Evaluate the Feasibility, Safety, and Efficacy of TET for FMT Via Colonic Approach', 'organization': {'class': 'OTHER', 'fullName': 'The Second Hospital of Nanjing Medical University'}, 'officialTitle': 'Feasibility, Safety, and Efficacy of Transendoscopic Enteral Tubing in Fecal Microbiota Transplantation', 'orgStudyIdInfo': {'id': 'TET-CN-121002'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'colonoscope via of FMT', 'description': 'FMT pathway is colonoscope', 'interventionNames': ['Device: colonoscope']}, {'label': 'Transendoscopic enteral tubing', 'description': 'FMT was performed via TET tube', 'interventionNames': ['Device: transendoscopic enteral tubing']}], 'interventions': [{'name': 'transendoscopic enteral tubing', 'type': 'DEVICE', 'otherNames': ['TET'], 'description': 'Investigators designed transendoscopic enteral tubing (TET).The enteral segment of the tube is fixed in the ileocecum with distal segment fixed buttocks. The tube was used for FMT and colonic local administration', 'armGroupLabels': ['Transendoscopic enteral tubing']}, {'name': 'colonoscope', 'type': 'DEVICE', 'description': 'FMT via colonoscope is the most common approach.', 'armGroupLabels': ['colonoscope via of FMT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210011', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Faming Zhang, MD, PhD', 'role': 'CONTACT', 'email': 'fzhang@njmu.edu.cn', 'phone': '086-25-58509883'}], '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'}], 'overallOfficials': [{'name': 'Faming Zhang, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Second Hospital of Nanjing Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Xijing Hospital of Digestive Diseases', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor, Gastroenterology', 'investigatorFullName': 'Faming Zhang', 'investigatorAffiliation': 'The Second Hospital of Nanjing Medical University'}}}}