Rescue Fecal Microbiota Transplantation for National Refractory Intestinal Infections

NCT03895593 | Recruiting DMC

• 1 other identifier: FMT-CN-190321
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intestinal Infection; Clostridioides Difficile Infection; Antibiotic-associated Diarrhea

Keywords

fecal microbiota transplantation; intestinal infection; clostridioides Difficile Infection; Antibiotic-associated Diarrhea; Washed microbiota transplantation

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (1)

• adverse events

  12 weeks

Interventions

rescue fecal microbiota transplantation OTHER

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

National patients with refractory intestinal infections receiving rescue FMT from the Chinese fmtBank from September, 2015 to December, 2029 will be included

Sponsors & Collaborators

• The Second Hospital of Nanjing Medical University: lead
• The First Affiliated Hospital of Zhengzhou University: collaborator
• First Affiliated Hospital of Xinjiang Medical University: collaborator
• Second Affiliated Hospital of Suzhou University: collaborator
• First Affiliated Hospital of Guangxi Medical University: collaborator
• Shenzhen Hospital of Southern Medical University: collaborator
• Wuhan University: collaborator
• LiuZhou People's Hospital: collaborator
• Lishui Country People's Hospital: collaborator

Study Sites (1)

Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210011, China

RECRUITING

Related Publications (8)

• 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.

  PMID: 29691757 BACKGROUND

• 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.

  PMID: 27602409 BACKGROUND

• 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.

  PMID: 25881250 BACKGROUND

• 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.

  PMID: 30020891 BACKGROUND

• 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.

  PMID: 28491142 BACKGROUND

• 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.

  PMID: 27751177 BACKGROUND

• 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.

  PMID: 37681235 DERIVED

• 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.

  PMID: 31639033 DERIVED

MeSH Terms

Conditions

Clostridium Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• faming zhang, MD,PhD

  The Second Hospital of Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

faming zhang, MD,PhD

CONTACT

086-025-58509883; fzhang@njmu.edu.cn

bota cui, MD,PhD

CONTACT

086-025-58509884; cuibota@njmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 27, 2019
• First Posted: March 29, 2019
• Study Start: September 25, 2015
• Primary Completion: May 1, 2024
• Study Completion (Estimated): May 1, 2029
• Last Updated: February 29, 2024

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)