Rescue Fecal Microbiota Transplantation for National Refractory Intestinal Infections

Antibiotic-associated Diarrhea Clinical Trial

Official title:

Rescue Fecal Microbiota Transplantation for Refractory Intestinal Infections: China National Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03895593
• Other study ID #: FMT-CN-190321
• Status: Recruiting
• 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
• 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.

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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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Related Conditions & MeSH terms

• Antibiotic-associated Diarrhea
• Clostridioides Difficile Infection
• Clostridium Infections
• Communicable Diseases
• Diarrhea
• Infections
• Intestinal Infection

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

External Links

•   China Microbiota Transplantation System