FMT to prevent acute GVHD

In a single-center, randomized, double-blind, placebo-controlled trial, we test the hypothesis that healthy donor oral encapsulated fecal microbiota transplantation (FMT) reduces the incidence of severe acute graft-versus-host disease (GVHD) after allogeneic hematopoietic cell transplantation. In the single-arm run-in phase of the trial, we compare 3 stool donors for microbiota and clinical outcomes of their corresponding patients, with the primary focus on microbiota engraftment. Three cohorts of patients each receive FMT from one of the 3 different stool donors. The best of these donors is selected as the sole stool donor for the randomized phase. Quality-filtered host-decontaminated fastq files generated by KneadData are shared. ClinicalTrials.gov identifier: NCT06026371