NCT03895593|RecruitingDMC
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Sponsor study identifier
observational
100
1 country
1
Study Start
September 25, 2015
Actual (reported)Primary Completion
May 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 25, 2015
Actual (reported)March 27, 2019
Actual (reported)March 29, 2019
Actual (reported)May 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
abdominal symptom outcomes
Definitions used to classify response, nonresponse and exacerbation for the abdominal symptom outcomes are based on the physicians' holistic evaluation of patients' abdominal symptoms.
1 week
survival outcome
The survival outcome refers to the 4-week survival post-FMT.
4 weeks
clinical cure of clostridioides difficile infection
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
8 weeks
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
National patients with refractory intestinal infections receiving rescue FMT from the Chinese fmtBank from September, 2015 to December, 2029 will be included
Contact the study team to confirm eligibility.
Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210011, China
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.
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.
faming zhang, MD,PhD
The Second Hospital of Nanjing Medical University
First Submitted
March 27, 2019
First Posted
March 29, 2019
Study Start
September 25, 2015
Actual (reported)Primary Completion
May 1, 2024
Estimated (date passed)Gut Microbiota Changes After Fecal Microbiota Transplantation
adverse events
12 weeks
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.
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.
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. Ther Adv Gastroenterol. 2017 Apr;10(4):373-381. doi: 10.1177/1756283X17690480. Epub 2017 Feb 8.
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.
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.
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.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
February 29, 2024
Record last verified: 2019-03
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