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.
Additional locations may be listed on ClinicalTrials.gov for NCT06026371.
Locations matching your search criteria
United States
Washington
Seattle
Fred Hutch/University of Washington/Seattle Children's Cancer ConsortiumStatus: Active
Contact: Armin Rashidi
Phone: 206-667-2506
PRIMARY OBJECTIVE:
I. Compare the probability of grade III-IV acute graft versus host disease (GVHD) rate at 6 months post-HCT between standard-of-care GVHD prophylaxis and fecal microbiota transplantation (FMT) when combined with standard-of-care GVHD prophylaxis.
SECONDARY OBJECTIVES:
I. Compare grade II-IV acute GVHD probabilities by 6 months post-HCT between FMT- and placebo-treated subjects.
II. Compare non-relapse mortality probabilities by 6 months post-HCT between FMT- and placebo-treated subjects.
III. Compare Clostridium difficile diarrhea rate by 6 months post-HCT between FMT- and placebo-treated subjects.
IV. Compare chronic GVHD rate by 12 months post-HCT between FMT- and placebo-treated subjects.
EXPLORATORY OBJECTIVES:
I. Determine donor microbiota engraftment in day-28 stool samples after the last FMT dose and compare between subjects developing grade III-IV acute GVHD vs. those developing grade I-II or no acute GVHD.
II. Determine clinical and microbiota predictors of donor microbiota engraftment.
III. Determine the effects of FMT on microbiota diversity, composition, and inferred metabolic function.
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. Patients undergo blood sample collection throughout the study.
GROUP II: Patients receive placebo PO QD for 7 days starting at the time of neutrophil engraftment and discontinuation of anti-bacterial antibiotics. Patients undergo blood sample collection throughout the study.
After completion of study intervention, patients are followed up monthly until 12 months post-allogeneic HCT.
Lead OrganizationFred Hutch/University of Washington/Seattle Children's Cancer Consortium
Principal InvestigatorArmin Rashidi
