Rescue Fecal Microbiota Transplantation for National Refractory Intestinal Infections

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT03895593

Recruitment Status : Recruiting

First Posted : March 29, 2019

Last Update Posted : May 14, 2019

See Contacts and Locations

Sponsor:

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

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
Intestinal Infection Clostridium Difficile Infection Antibiotic-associated Diarrhea	Other: rescue fecal microbiota transplantation

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

Layout table for study information

Study Type :	Observational
Estimated Enrollment :	100 participants
Observational Model:	Case-Only
Time Perspective:	Retrospective
Official Title:	Rescue Fecal Microbiota Transplantation for Refractory Intestinal Infections: China National Registry
Actual Study Start Date :	September 25, 2015
Estimated Primary Completion Date :	May 1, 2024
Estimated Study Completion Date :	May 1, 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

U.S. FDA Resources

Groups and Cohorts

Intervention Details:

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

Outcome Measures

Primary Outcome Measures :

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.

Secondary Outcome Measures :

adverse events [ Time Frame: 12 weeks ]
Unfavorable signs, symptoms, or major changes from pre-FMT laboratory test results.

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study:	Child, Adult, Older Adult
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
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

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03895593

Contacts

Layout table for location 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

Locations

Layout table for location information

China, Jiangsu
Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University	Recruiting
Nanjing, Jiangsu, China, 210011
Contact: Faming Zhang, MD, PhD 086-25-58509883 fzhang@njmu.edu.cn

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

Layout table for investigator information

Principal Investigator:	faming zhang, MD,PhD	The Second Hospital of Nanjing Medical University

More Information

Additional Information:

China Microbiota Transplantation System This link exits the ClinicalTrials.gov site

China fecal microbiota transplantation bank This link exits the ClinicalTrials.gov site

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Layout table for additonal information

Responsible Party:	The Second Hospital of Nanjing Medical University
ClinicalTrials.gov Identifier:	NCT03895593
Other Study ID Numbers:	FMT-CN-190321
First Posted:	March 29, 2019 Key Record Dates
Last Update Posted:	May 14, 2019
Last Verified:	March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Layout table for additional information

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

Keywords provided by The Second Hospital of Nanjing Medical University:


fecal microbiota transplantation intestinal infection Clostridium Difficile Infection Antibiotic-associated Diarrhea

Additional relevant MeSH terms:

Layout table for MeSH terms

Infection Communicable Diseases Clostridium Infections Diarrhea	Signs and Symptoms, Digestive Gram-Positive Bacterial Infections Bacterial Infections

To Top