Rescue Fecal Microbiota Transplantation for National Refractory Intestinal Infections

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• 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

Trial sites (1)

More The Second Hospital of Nanjing Medical University trials in China

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