This randomized placebo-controlled double-blind phase II trial tests whether fecal microorganism (microbiota) transplantation prevents severe acute graft versus host disease in adults undergoing allogeneic hematopoietic cell transplantation (HCT). Fecal microbiota transplantation involves receiving processed fecal material orally after allogeneic HCT in order to establish a healthy gut microbiota. Gut microbiota undergoes major alterations during allogeneic HCT because of antibiotic exposures, nutritional changes, and chemotherapy administration. Establishing a healthy gut microbiota via fecal transplantation may help prevent acute graft versus host disease in patients undergoing allogeneic HCT.
OUTLINE: The first 12 patients are assigned to group I, remaining patients are randomized to 1 of 2 groups. GROUP I: Patients receive fecal microbiota capsules orally (PO) once daily (QD) for 7 days starting at the time of neutrophil engraftment and discontinuation of anti-bacterial antibiotics. GROUP II: Patients receive placebo PO QD for 7 days starting at the time of neutrophil engraftment and discontinuation of anti-bacterial antibiotics. After completion of study intervention, patients are followed up monthly until 12 months post-allogeneic HCT.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
138
Given PO
Given PO
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
Grade III-IV acute graft versus host disease (GVHD)
Based on International Blood and Marrow Transplantation Research (IBMTR) criteria and measured as a probability
Time frame: Up to 6 months post hematopoietic cell transplantation (HCT)
Grade II-IV acute GVHD
Based on IBMTR criteria and measured as a probability
Time frame: Up to 180 days post HCT
Non-relapse mortality
Death not due to relapse/progression of the underlying hematologic disorder and measured as a probability
Time frame: Up to 180 days post HCT
Clostridium difficile diarrhea
Based on a positive stool assay in the consistent clinical setting (e.g. diarrhea) and measured as a probability
Time frame: Up to 180 days post HCT
Chronic GVHD
Diagnosis based on the National Institutes of Health Consensus Criteria (PMID: 25529383)
Time frame: At 12 months post-HCT
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