Rescue Fecal Microbiota Transplantation for National Refractory Intestinal Infections
Study Details
Study Description
Brief Summary
A national data registry of patients receiving the rescue fecal microbiota transplantation for the refractory intestinal infections from the Chinese fmtBank designed to assess the short-term and long-term safety and efficacy.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
This registry will enroll national patients with refractory intestinal infections receiving rescue fecal microbiota transplantation (FMT) from the Chinese fmtBank, from September 2015 to February 2019. Data of demographic characteristics, symptoms of intestinal infections, previous medicine treatment and clinical outcomes will be collected retrospectively abstracted from the electronic medical records. 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.
Study Design
Outcome Measures
Primary Outcome Measures
- abdominal symptom outcomes [1 week]
Definitions used to classify response, nonresponse and exacerbation for the abdominal symptom outcomes are based on the physicians' holistic evaluation of patients' abdominal symptoms.
- survival outcome [4 weeks]
The survival outcome refers to the 4-week survival post-FMT.
Secondary Outcome Measures
- adverse events [12 weeks]
Unfavorable signs, symptoms, or major changes from pre-FMT laboratory test results.
Eligibility Criteria
Criteria
Inclusion Criteria: National patients with refractory intestinal infections receiving rescue FMT from the Chinese fmtBank from September 2015 to February 2019 will be included.
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Exclusion Criteria: Patients will be excluded from the analysis if they are not followed up for at least 12 weeks post-FMT.
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Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University | Nanjing | Jiangsu | China | 210011 |
Sponsors and Collaborators
- The Second Hospital of Nanjing Medical University
- The First Affiliated Hospital of Zhengzhou University
- First Affiliated Hospital of Xinjiang Medical University
- Second Affiliated Hospital of Suzhou University
- First Affiliated Hospital of Guangxi Medical University
- Shenzhen Hospital of Southern Medical University
- Wuhan University
- LiuZhou People's Hospital
- Lishui Country People's Hospital
Investigators
- Principal Investigator: faming zhang, MD,PhD, The Second Hospital of Nanjing Medical University
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- 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;19:37. 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.
- 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). pii: e00199-16. doi: 10.1128/mSphere.00199-16. eCollection 2016 Jul-Aug.
- 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. Review.
- 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.
- 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. Review.
- FMT-CN-190321