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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03895593
Other study ID # FMT-CN-190321
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 25, 2015
Est. completion date May 1, 2029

Study information

Verified date March 2019
Source The Second Hospital of Nanjing Medical University
Contact faming zhang, MD,PhD
Phone 086-025-58509883
Email fzhang@njmu.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date May 1, 2029
Est. primary completion date May 1, 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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. - Exclusion Criteria: Patients will be excluded from the analysis if they are not followed up for at least 12 weeks post-FMT. -

Study Design


Related Conditions & MeSH terms


Intervention

Other:
rescue fecal microbiota transplantation
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.

Locations

Country Name City State
China Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University Nanjing Jiangsu

Sponsors (9)

Lead Sponsor Collaborator
The Second Hospital of Nanjing Medical University First Affiliated Hospital of Guangxi Medical University, First Affiliated Hospital of Xinjiang Medical University, Lishui Country People's Hospital, LiuZhou People's Hospital, Second Affiliated Hospital of Suzhou University, Shenzhen Hospital of Southern Medical University, The First Affiliated Hospital of Zhengzhou University, Wuhan University

Country where clinical trial is conducted

China, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary survival outcome The survival outcome refers to the 4-week survival post-FMT. 4 weeks
Primary 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
Secondary adverse events Unfavorable signs, symptoms, or major changes from pre-FMT laboratory test results. 12 weeks
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