After nearly seven decades on the fringes of medicine, fecal microbiota transplantation has finally crossed a regulatory and clinical threshold. FDA-approved, microbiota-based therapies are now part of formal treatment algorithms, and updated professional guidelines have brought long-awaited clarity on when — and how — FMT should be used.
But the picture isn’t uniformly progressive.
In recurrent Clostridioides difficile infection, FMT has firmly earned its place, supported by randomized trials, real-world outcomes, and explicit recommendations from the American Gastroenterological Association. At the same time, practical access to conventional FMT has quietly tightened in 2025, following the withdrawal of a major stool bank — a reminder that regulatory approval doesn’t always translate to bedside availability.
Beyond CDI, the story becomes more complicated. Interest in applying FMT to IBD and IBS continues to grow as understanding of the gut microbiome deepens. Yet evidence remains uneven, and enthusiasm is now tempered by the realization that microbiome modulation is not a one-size-fits-all solution.
The review frames FMT’s trajectory accurately: decades of progress, landmark validation, and expanding scientific insight — followed by new logistical, evidentiary, and regulatory friction.
FMT may be further along than ever before. But whether it becomes routine outside CDI — or gives way to more refined microbiome-based therapies — is still very much an open question.
