Rescue Fecal Microbiota Transplantation for National Refractory Intestinal Infections

• ClinicalTrials.gov Identifier: NCT03895593
• Recruitment Status: Recruiting
• First Posted: March 29, 2019
• Last Update Posted: May 14, 2019
• Sponsor: The Second Hospital of Nanjing Medical University
• Collaborators: 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
• Information provided by (Responsible Party): The Second Hospital of Nanjing Medical University

Tracking Information

• First Submitted Date: March 27, 2019
• First Posted Date: March 29, 2019
• Last Update Posted Date: May 14, 2019
• Actual Study Start Date: September 25, 2015
• Estimated Primary Completion Date: May 1, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 27, 2019)

• abdominal symptom outcomes [ Time Frame: 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 [ Time Frame: 4 weeks ]
  The survival outcome refers to the 4-week survival post-FMT.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 12, 2019)

adverse events [ Time Frame: 12 weeks ]

Unfavorable signs, symptoms, or major changes from pre-FMT laboratory test results.

Original Secondary Outcome Measures (submitted: March 27, 2019)

advertise events [ Time Frame: 12 weeks ]

Unfavorable signs, symptoms, or major changes from pre-FMT laboratory test results.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Rescue Fecal Microbiota Transplantation for National Refractory Intestinal Infections
• Official Title: Rescue Fecal Microbiota Transplantation for Refractory Intestinal Infections: China National Registry
• 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.
• 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 Type: Observational
• Study Design: Observational Model: Case-Only; Time Perspective: Retrospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: National patients with refractory intestinal infections receiving rescue FMT from the Chinese fmtBank from September, 2015 to February, 2019 will be included

Condition

• Intestinal Infection
• Clostridium Difficile Infection
• Antibiotic-associated Diarrhea

Intervention

Other: rescue fecal microbiota transplantation

Fecal microbiota transplantation refers to the infusion of fecal microbiota from healthy donor into patients' gastrointestinal tract.

• Study Groups/Cohorts: Not Provided

Publications *

• 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.
• 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.
• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: March 27, 2019): 100
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: May 1, 2029
• Estimated Primary Completion Date: May 1, 2024 (Final data collection date for primary outcome measure)

Eligibility 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.

-

Exclusion Criteria: Patients will be excluded from the analysis if they are not followed up for at least 12 weeks post-FMT.

-

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No

Contacts

Contact: faming zhang, MD,PhD; 086-025-58509883; fzhang@njmu.edu.cn

Contact: bota cui, MD,PhD; 086-025-58509884; cuibota@njmu.edu.cn

• Listed Location Countries: China

Administrative Information

• NCT Number: NCT03895593
• Other Study ID Numbers: FMT-CN-190321
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: The Second Hospital of Nanjing Medical University
• Study Sponsor: The Second Hospital of Nanjing Medical University

Collaborators

• 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

• PRS Account: The Second Hospital of Nanjing Medical University
• Verification Date: March 2019