Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2026-02-27 @ 4:31 PM
Study NCT ID:
NCT03895593
Status:
RECRUITING
Last Update Posted:
2024-02-29
First Post:
2019-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rescue Fecal Microbiota Transplantation for National Refractory Intestinal Infections
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003015', 'term': 'Clostridium Infections'}], 'ancestors': [{'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-09-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2029-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-27', 'studyFirstSubmitDate': '2019-03-27', 'studyFirstSubmitQcDate': '2019-03-27', 'lastUpdatePostDateStruct': {'date': '2024-02-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'abdominal symptom outcomes', 'timeFrame': '1 week', 'description': "Definitions used to classify response, nonresponse and exacerbation for the abdominal symptom outcomes are based on the physicians' holistic evaluation of patients' abdominal symptoms."}, {'measure': 'survival outcome', 'timeFrame': '4 weeks', 'description': 'The survival outcome refers to the 4-week survival post-FMT.'}, {'measure': 'clinical cure of clostridioides difficile infection', 'timeFrame': '8 weeks', 'description': 'clinical resolution (absence of diarrhea, or marked reduction in stool frequency), or a negative clostridioides difficile (CD) test, without the need for further anti-clostridioides difficile infection therapy'}], 'secondaryOutcomes': [{'measure': 'adverse events', 'timeFrame': '12 weeks', 'description': 'Unfavorable signs, symptoms, or major changes from pre-FMT laboratory test results.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['fecal microbiota transplantation', 'intestinal infection', 'clostridioides Difficile Infection', 'Antibiotic-associated Diarrhea', 'Washed microbiota transplantation'], 'conditions': ['Intestinal Infection', 'Clostridioides Difficile Infection', 'Antibiotic-associated Diarrhea']}, 'referencesModule': {'references': [{'pmid': '29691757', 'type': 'BACKGROUND', 'citation': 'Zhang F, Cui B, He X, Nie Y, Wu K, Fan D; FMT-standardization Study Group. Microbiota transplantation: concept, methodology and strategy for its modernization. Protein Cell. 2018 May;9(5):462-473. doi: 10.1007/s13238-018-0541-8. Epub 2018 Apr 24.'}, {'pmid': '27602409', 'type': 'BACKGROUND', 'citation': 'McDonald D, Ackermann G, Khailova L, Baird C, Heyland D, Kozar R, Lemieux M, Derenski K, King J, Vis-Kampen C, Knight R, Wischmeyer PE. Extreme Dysbiosis of the Microbiome in Critical Illness. mSphere. 2016 Aug 31;1(4):e00199-16. doi: 10.1128/mSphere.00199-16. eCollection 2016 Jul-Aug.'}, {'pmid': '25881250', 'type': 'BACKGROUND', 'citation': 'Li Q, Wang C, Tang C, He Q, Zhao X, Li N, Li J. Successful treatment of severe sepsis and diarrhea after vagotomy utilizing fecal microbiota transplantation: a case report. Crit Care. 2015 Feb 9;19(1):37. doi: 10.1186/s13054-015-0738-7.'}, {'pmid': '30020891', 'type': 'BACKGROUND', 'citation': 'Litao G, Jingjing S, Yu L, Lei Z, Xiaona H, Zhijing Z. Risk Factors for Antibiotic-Associated Diarrhea in Critically Ill Patients. Med Sci Monit. 2018 Jul 18;24:5000-5007. doi: 10.12659/MSM.911308.'}, {'pmid': '28491142', 'type': 'BACKGROUND', 'citation': 'van Beurden YH, Nieuwdorp M, van de Berg PJEJ, Mulder CJJ, Goorhuis A. Current challenges in the treatment of severe Clostridium difficile infection: early treatment potential of fecal microbiota transplantation. Therap Adv Gastroenterol. 2017 Apr;10(4):373-381. doi: 10.1177/1756283X17690480. Epub 2017 Feb 8.'}, {'pmid': '27751177', 'type': 'BACKGROUND', 'citation': 'Wei Y, Yang J, Wang J, Yang Y, Huang J, Gong H, Cui H, Chen D. Successful treatment with fecal microbiota transplantation in patients with multiple organ dysfunction syndrome and diarrhea following severe sepsis. Crit Care. 2016 Oct 18;20(1):332. doi: 10.1186/s13054-016-1491-2.'}, {'pmid': '37681235', 'type': 'DERIVED', 'citation': 'Wu X, Ai RJ, Xu J, Wen Q, Pan HQ, Zhang ZH, Ning W, Fang Y, Ding DF, Wang Q, Han S, Liu X, Wu M, Jia ZY, Jia S, Lin T, Cui BT, Nie YZ, Wang X, Zhang FM. Washed microbiota transplantation for Clostridioides difficile infection: A national multicenter real-world study. J Dig Dis. 2023 Oct;24(10):540-549. doi: 10.1111/1751-2980.13227. Epub 2023 Oct 5.'}, {'pmid': '31639033', 'type': 'DERIVED', 'citation': 'Dai M, Liu Y, Chen W, Buch H, Shan Y, Chang L, Bai Y, Shen C, Zhang X, Huo Y, Huang D, Yang Z, Hu Z, He X, Pan J, Hu L, Pan X, Wu X, Deng B, Li Z, Cui B, Zhang F. Rescue fecal microbiota transplantation for antibiotic-associated diarrhea in critically ill patients. Crit Care. 2019 Oct 21;23(1):324. doi: 10.1186/s13054-019-2604-5.'}]}, 'descriptionModule': {'briefSummary': 'A national data registry of patients receiving the rescue fecal microbiota transplantation for the refractory intestinal infections from the China Microbiota Transplantation System was designed to assess the short-term and long-term safety and efficacy.', 'detailedDescription': 'This registry will enroll national patients with refractory intestinal infections (including clostridioides difficile infection, other infections with known or unknown pathogens) receiving rescue fecal microbiota transplantation (FMT) from the the China Microbiota Transplantation System. The improved methodology of FMT based on the automatic washing process and the related delivering consideration was named as washed microbiota transplantation (WMT) by the consensus statement from the FMT-standardization study group in 2019.12. Data of demographic characteristics, symptoms of intestinal infections, previous medicine treatment and clinical outcomes will be collected retrospectively abstracted from the electronic medical records or prospective follow-up. All the patients will be followed up for at least 12 weeks post-FMT. Information on follow-up will be designed to assess the short-term and long-term adverse events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'National patients with refractory intestinal infections receiving rescue FMT from the Chinese fmtBank from September, 2015 to December, 2029 will be included', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: National patients with refractory intestinal infections receiving rescue FMT from the China Microbiota Transplantation System from September 2015 to December, 2029 will be included.\n\n\\-\n\nExclusion Criteria: Patients will be excluded from the analysis if they are not followed up for at least 12 weeks post-FMT.\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03895593', 'briefTitle': 'Rescue Fecal Microbiota Transplantation for National Refractory Intestinal Infections', 'organization': {'class': 'OTHER', 'fullName': 'The Second Hospital of Nanjing Medical University'}, 'officialTitle': 'Rescue Fecal Microbiota Transplantation for Refractory Intestinal Infections: China National Registry', 'orgStudyIdInfo': {'id': 'FMT-CN-190321'}}, 'armsInterventionsModule': {'interventions': [{'name': 'rescue fecal microbiota transplantation', 'type': 'OTHER', 'description': "Fecal microbiota transplantation refers to the infusion of fecal microbiota from healthy donor into patients' gastrointestinal tract. The delivering ways for FMT include but are not limited to gastroscopy, colonoscopy, edema, nasogastric tube, transendoscopic enteral tube, and etc."}]}, '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': '086-025-58509883'}, {'name': 'bota cui, MD,PhD', 'role': 'CONTACT', 'email': 'cuibota@njmu.edu.cn', 'phone': '086-025-58509884'}], 'overallOfficials': [{'name': 'faming zhang, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Second Hospital of Nanjing Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Second Hospital of Nanjing Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'The First Affiliated Hospital of Zhengzhou University', 'class': 'OTHER'}, {'name': 'First Affiliated Hospital of Xinjiang Medical University', 'class': 'OTHER'}, {'name': 'Second Affiliated Hospital of Suzhou University', 'class': 'OTHER'}, {'name': 'First Affiliated Hospital of Guangxi Medical University', 'class': 'OTHER'}, {'name': 'Shenzhen Hospital of Southern Medical University', 'class': 'OTHER'}, {'name': 'Wuhan University', 'class': 'OTHER'}, {'name': "LiuZhou People's Hospital", 'class': 'OTHER'}, {'name': "Lishui Country People's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Faming Zhang', 'investigatorAffiliation': 'The Second Hospital of Nanjing Medical University'}}}}