Fecal Microbiota Transplantation for C. Difficile Infection in Solid Organ Transplant Recipients

Clostridium difficile (C.difficile) is a pathogen of major public health
importance,especially in individuals with comorbid conditions such as solid organ
transplantation(SOT). The incidence and adverse outcomes of CDI are greatly amplified in the
setting of SOT, due to healthcare exposure, antibiotic use and immunosuppression, all of
which are ubiquitous in SOT recipients. There are currently no effective treatment options to
achieve a sustained cure of recurrent CDI and prevent further recurrence in SOT recipients. A
novel approach that has recently gained attention is restoration of the CDI impaired gut
microbiome by instillation of stool from a healthy donor into the intestine of a CDI patient.
This treatment, called Fecal Microbiota Transplantation (FMT) has been found in
non-comparative studies to reduce CDI recurrence dramatically with a reported efficacy of
over 95%, however its efficacy in SOT recipients has not been studied and cannot be
extrapolated from results in the non-SOT population because SOT recipients are a unique study
population due to profound immunosuppression, frequent antibiotic use and frequent
opportunities for exposure to CDI all of which markedly, repeatedly and persistently disrupt
the gut microbiome. Thus, this critical gap in the field needs to be addressed by a trial of
FMT in SOT recipients with CDI.

Inclusion Criteria:

- Is able to provide written informed consent

- Is a solid organ transplant (SOT) recipient

- Has had at least a first recurrence of C. difficile infection defined as: positive C.
difficile testing in stool and diarrhea (three or more loose stools over 24 hours)
during the 60 day period following completion of treatment for prior episode.

- No more than 3 CDI recurrences

- Negative pregnancy test for women of childbearing potential and agree to use effective
form of contraception until 6 weeks post treatment

- Clinical response to 4-7 days of oral antibiotic standard of care treatment for the
current episode of CDI

Exclusion Criteria:

- Has a history of chronic or active intestinal disease (e.g. Crohn's disease,
ulcerative colitis)

- Is unable to complete a daily stool diary (mental incapacity, head trauma, etc.)

- Has presence of toxic megacolon or ileus

- Has presence of colostomy

- Is enrolled in another investigational drug trial

- Is severely immunocompromised (≥ 80 or more mg of prednisone or equivalent daily)

- Is unavailable for follow-up visits

- Is taking concomitant antibiotics at time of enrollment for anything other than for
treatment of current CDI

- Is taking probiotics at enrollment and unwilling to discontinue

- Has received an investigational product or been treated with an investigational device
within 30 days prior to visit #1

- Co-infection with another intestinal pathogen