This randomized clinical trial studies how well an autologous fecal microbiota transplant works in preventing Clostridium difficile infection in patients with cancer undergoing a donor hematopoietic stem cell transplant. In autologous fecal microbiota transplant, the patient's own healthy feces are administered to their intestinal tract through the rectum, in order to restore the healthy bacteria. An autologous fecal transplant may prevent Clostridium difficile infection from occurring in transplant patients who are found to have lost their normal gut (intestinal tract) bacteria.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02269150.
PRIMARY OBJECTIVES:
I. To determine if prophylactic autologous fecal microbiota transplantation can reduce the incidence of post-engraftment Clostridium (C.) difficile infection (CDI) in patients undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT).
SECONDARY OBJECTIVES:
I. To evaluate if autologous fecal microbiota transplantation (auto-FMT) can lead to decreased incidence of systemic and/or intestinal bacterial/viral infection(s).
II. To evaluate for auto-FMT’s effect on incidence of graft-versus-host disease (GVHD).
III. To evaluate if auto-FMT can lead to increased overall survival and/or deceased transplant-related mortality.
IV. To assess differences in intestinal microbiota between study arms.
V. To identify microbiota markers signifying increased or decreased risk for C. difficile infection and GVHD.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I (FMT TRANSPLANT): Patients undergo autologous fecal microbiota transplantation within 28 days after stem cell engraftment.
ARM II (CONTROL): Patients receive standard transplant care.
After completion of study treatment, patients are followed up monthly for 1 year.
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorYing Taur
