Rescue Fecal Microbiota Transplantation for National Refractory Intestinal Infections
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorThe Second Hospital of Nanjing Medical University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
National patients with refractory intestinal infections receiving rescue FMT from the Chinese fmtBank from September, 2015 to December, 2029 will be included
Trial design
Design model
Case-only
Time perspective
Retrospective
Treatments tested in this trial
rescue fecal microbiota transplantation
Other interventionFecal 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
1 week2
survival outcome
The survival outcome refers to the 4-week survival post-FMT.
Time frame
4 weeks3
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
Time frame
8 weeksSecondary outcomes
1
adverse events
Unfavorable signs, symptoms, or major changes from pre-FMT laboratory test results.
Time frame
12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
The Second Hospital of Nanjing Medical University
Lead sponsor
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
Source ClinicalTrials.gov