Rescue Fecal Microbiota Transplantation for National Refractory Intestinal Infections

Study Overview
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Brief Summary
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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
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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.

Official Title
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Rescue Fecal Microbiota Transplantation for Refractory Intestinal Infections: China National Registry

Conditions
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Intestinal Infection, Clostridioides Difficile Infection, Antibiotic-associated Diarrhea

Intervention / Treatment
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* Other: rescue fecal microbiota transplantation


Participation Criteria
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Eligibility Criteria
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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. -
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: rescue 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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse events | Unfavorable signs, symptoms, or major changes from pre-FMT laboratory test results. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antibiotic-associated Diarrhea, Washed microbiota transplantation, fecal microbiota transplantation, intestinal infection, clostridioides Difficile Infection