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Trial record 2 of 2 for:    FMT National registry

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
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

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
Change History
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 *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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