National Registry Study of Rescue Fecal Microbiota Transplantation for Difficult Intestinal Infections in China

What this Trial Is About

Researchers are collecting data from patients across the country who have refractory intestinal infections, such as Clostridioides difficile infection or other infections with known or unknown causes, and who receive rescue fecal microbiota transplantation FMT through the China Microbiota Transplantation System. The goal is to assess both the short-term and long-term safety and effectiveness of this treatment approach. This registry study includes patients treated from September 2015 through December 2029. The treatment being studied is rescue fecal microbiota transplantation, which involves transferring fecal microbiota from healthy donors into the patients digestive tract. Various delivery methods may be used, including gastroscopy, colonoscopy, nasogastric tube, and other endoscopic techniques. The FMT method used is improved and called washed microbiota transplantation WMT, which follows a standardized washing process and delivery approach. Participants data such as demographics, infection symptoms, prior medication use, and clinical outcomes will be collected either retrospectively from medical records or through prospective follow-up. All patients will be followed for at least 12 weeks after FMT to monitor adverse events and treatment effects. Primary outcomes include abdominal symptom changes at 1 week, survival at 4 weeks, and clinical cure of Clostridioides difficile infection at 8 weeks. Secondary outcomes include adverse events observed at 12 weeks.

Rescue Fecal Microbiota Transplantation for National Refractory Intestinal Infections