Recurrent Clostridium Difficile Infection Clinical Trial
Official title:
A Prospective Double Blind Randomized Pilot Study Comparing the Efficacy of Lyophilized Fecal Microbiota Transplantation (FMT) to Lyophilized Sterile Fecal Filtrate in the Management of Recurrent Clostridium Difficile Infection (CDI)
Fecal microbiota transplantation (FMT) for the treatment of recurrent Clostridium difficile
infection (RCDI) has traditionally been offered as fecal slurry administered by enema,
nasogastric tube or endoscopy. Frozen oral capsules have also shown efficacy. The potential
advantage of lyophilized FMT is the relative ease of manufacturing and storage compared with
fecal slurry.
Sterile fecal filtrate has previously been shown to prevent Clostridium difficile infection
(CDI) recurrence, suggesting that live bacteria may not be needed. This study will compare
lyophilized sterile fecal filtrate (LSFF) with lyophilized FMT (LFMT) in the treatment of
recurrent Clostridium difficile infection (RCDI).
This prospective double blind randomized pilot study will enroll 40 subjects with recurrent
Clostridium difficile infection in a 1:1 ratio to receive either LSFF or LFMT by capsules.
Subjects will receive 15 capsules at week 0 and be assessed at Weeks 1, 4, 12 and 24. If
treatment fails, subjects will be given open label LFMT from the same donor. If treatment
fails again, another FMT will be offered and the form and route of FMT delivery will be at
the discretion of the treating physician.
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