Antibiotic-associated Diarrhea, Clostridioides Difficile Infection, Intestinal Infection
Conditions
Keywords
fecal microbiota transplantation, intestinal infection, clostridioides Difficile Infection, Antibiotic-associated Diarrhea, Washed microbiota transplantation
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.
Detailed description
This registry will enroll national patients with refractory intestinal infections (including clostridioides difficile infection, other infections with known or unknown pathogens) receiving rescue fecal microbiota transplantation (FMT) from the the China Microbiota Transplantation System. The improved methodology of FMT based on the automatic washing process and the related delivering consideration was named as washed microbiota transplantation (WMT) by the consensus statement from the FMT-standardization study group in 2019.12. Data of demographic characteristics, symptoms of intestinal infections, previous medicine treatment and clinical outcomes will be collected retrospectively abstracted from the electronic medical records or prospective follow-up. 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.
Interventions
OTHERrescue fecal microbiota transplantation
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.
Sponsors
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
The Second Hospital of Nanjing Medical University
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
National patients with refractory intestinal infections receiving rescue FMT from the China Microbiota Transplantation System from September 2015 to December, 2029 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. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| abdominal symptom outcomes | 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 | 4 weeks | The survival outcome refers to the 4-week survival post-FMT. |
| clinical cure of clostridioides difficile infection | 8 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| adverse events | 12 weeks | Unfavorable signs, symptoms, or major changes from pre-FMT laboratory test results. |
Countries
China
Contacts
Primary Contactfaming zhang, MD,PhD
Backup Contactbota cui, MD,PhD
Outcome results
None listed