Freeze-dried Bacteria

Research trial comparing the effectiveness of lysophilized sterile fecal filtrate (LSFF) to lysophilized fecal microbiota transplantation (LFMT) in the management of Clostridium difficile infection (rCDI).

  • Traditionally, FMT has been offered as fecal slurry, administered by enema, nasogastric tubes, or endoscopy, given its ease of preparation. 
  • Although more labor intensive to manufacture, frozen oral encapsulated FMT is easier and cheaper to administer, and has shown clinical efficacy in RCDI. The potential advantage of lyophilized FMT over frozen encapsulated FMT is that the former formulation does not require a deep freezer while still demonstrating efficacy. 
  • Stately and colleagues have achieved cure in 43 of 49 patients suffering from RCDI with lyophilized FMT. Remarkably, a recent study by Ott and colleagues demonstrated that sterile fecal filtrate, free of live bacteria, delivered via nasogastric tube could prevent further CDI recurrence in 5 patients. 
  • Interestingly, not only did they find significant changes in bacteriophage composition in the recipients, with engraftment of bacteriophages from donors, but also changes in the bacterial composition which did not necessarily mirror or resemble that of the donor.

  • This is a multi-center, double blind, randomized trial – a gold standard in research design.

    • A total of 248 patients with at least 3 episodes of CDI were enrolled in the study
    • Patients either received 15 capsules of LSFF or LFMT.
    Primary outcome:
    • Proportion of patients without recurrent CDI in each arm after 8 weeks.