Autologous Fecal Microbiota Transplantation (Auto-FMT) for Prophylaxis of Clostridium Difficile Infection in Recipients of Allogeneic Hematopoietic Stem Cell Transplantation
Allogeneic Hematopoietic Stem Cell
About this trial
This is an interventional treatment trial for Allogeneic Hematopoietic Stem Cell focused on measuring Recipients, Transplantation
Eligibility Criteria
Inclusion Criteria:
- Planned to undergo allo-HSCT
- Age ≥ 18 years
Exclusion Criteria:
- As determined by the study investigators or consenting professionals, prolonged antibiotic treatment, as prevention or suppression of an ongoing infection, where treatment involves gut-perturbing antianaerobic antibiotics
- Has severe colitis of any etiology or a history of inflammatory bowel disease (IBD).
Sites / Locations
- Memorial Sloan Kettering Cancer Center
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Fecal microbiota transplantation with pre-transplant feces
No FMT, routine management
Prior to transplant hospitalization, store feces for testing and possible future use. Patients undergo fecal microbiota transplantation with the subject's stored pre-transplantation feces. The post-engraftment Bacteroidetes testing, randomization, and fecal microbiota transplantation procedure should all be performed within a 28-day window, beginning on the first day of engraftment. In the event that engraftment occurs prior to day +7, the 28-day window will start on day +7. Subjects from both arms will be followed for one year after transplantation for development of CDI, which will be treated by their BMT clinicians per the standards of care at MSKCC. Subjects from both arms will also be assessed for infections and graft-versus-host disease. During the follow-up period, fecal specimens will be collected serially, if feasible, until one year post randomization and analyzed for microbial diversity and composition.
Subjects from both arms will be followed for one year after randomization for development of CDI, which will be treated by their primary BMT clinician per the standards of care at MSKCC. Subjects from both arms will also be assessed by their BMT clinicians for infections and graft-versus-host disease. During the follow-up period, fecal specimens will be collected serially if feasible until one year post randomization and analyzed for microbial diversity and composition.