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Fecal microbiota transplantation (FMT) is a microbial therapy developed by Sheba Medical Center for the treatment of steroid-resistant or steroid-dependent gut acute graft-versus-host disease (aGVHD). The intervention consists of oral capsules containing frozen fecal microbiota harvested from healthy, unrelated donors. The therapeutic rationale is based on the observation that allogeneic hematopoietic stem cell transplantation (HSCT) causes significant perturbations in the intestinal microbiome (dysbiosis), which are linked to the pathogenesis of aGVHD. By reintroducing a diverse community of commensal microorganisms, FMT aims to restore gut homeostasis and modulate the immune-mediated inflammatory response characteristic of GVHD. This specific formulation is being evaluated in a Phase 1 pilot study to assess its safety and feasibility in adult HSCT recipients.
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