Safety and Efficacy of Fecal Microbiota Transplantation in Patients with a History of Solid Organ Transplant and C. Difficile Infection

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Medicine and Health Sciences


Clostridium difficile infection is particularly common in SOT patients and the consequences are severe. Fecal microbiota transplantation is an emerging, highly efficacious therapeutic modality for CDI but data on FMT success in SOT patients is scarce. This study is a retrospective, observational study, collecting a large number of cases to assess the safety and efficacy of FMT in the SOT population from our FMT database. The specific aims of the proposal are 1. To identify SOT recipients prior to undergoing FMT (organ type, antirejection medications used) 2. To characterize CDI by severity, number of recurrences, antibiotic therapies 3. To characterize FMT for efficacy and safety 4. To characterize SOT course following FMT Inclusion criteria: 1. Established solid organ transplant (SOT) recipient prior to first Fecal Microbiota transplantation. 2. Clostridium difficile infection (CDI) treated with fecal microbiota transplantation (FMT) 3. No Exclusion criteria were present. Study Procedures: This study is a retrospective and observational study of patients with SOT treated with FMT for CDI since 2012. Outside institutions will be asked to participate. Data will be extracted from FMT research databases and from review of electronic medical records. Data points that will be collected include basic demographic information, SOT characteristics, CDI severity prior and following FMT procedure, details of treatments used for CDI and SOT, documented comorbidities, and success of FMT at 1 month and 3 month following procedure through PCR testing. (Appendix A: data collection sheet). Other institutions will use the data collection sheet in the appendix. All of the information will be de-identified when it is sent to us. The patient # is NOT the MRN, but only a number assigned to each subject to keep track of entries. We will not be sent any identifiable information from other institutions. Data collection sheets from our site will also be de-identified. Statistical Considerations: Data interpretation will be performed using descriptive statistical methods. Conclusion: The project is currently being finalized and will be formally submitted to the American College of Gastroenterology by the end of this month.


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