Stool Transplants to Treat Refractory Clostridium Difficile Colitis

Recurrent colitis due to Clostridium difficile results from disruption of the normal gut
flora, and is very difficult to treat. It is now clear that restoration of the normal gut
flora is the most effective way to treat recurrent C. difficile colitis. Restoration of the
normal gut flora is best done by transplanting stool from a healthy donor, and this is
accepted as a superior therapeutic modality for recurrent C. difficile colitis. This fecal
microbiota transplantation can be done with direct instillation of the donor stool into the
GI tract via a naso-duodenal tube or colonoscope. Recently, a non-invasive method of stool
transplantation has been developed where the donor stool is encapsulated and administered in
pill form. The investigators would like to use fecal microbiota transplantation with
encapsulated stool as a non-invasive therapy for patients with recurrent C. difficile
colitis. To qualify, patients must have a history of, at least, 3 episodes of C difficile
colitis within the past year or, at least, 2 episodes of C difficile colitis that resulted in
hospitalization. Stool samples will be obtained from healthy volunteers who have been
screened for infections that can be transmitted via stool, and the investigators will prepare
capsules containing processed stool for administration during a single outpatient clinic
visit. Patients will be followed closely after administration of the fecal transplant with
serial clinic visits, and the primary endpoint will be prevention of any further episodes of
C. difficile colitis in the six month period following transplantation. The investigators
will also obtain and store stool samples from patients before and after fecal microbiota
transplantation for possible future microbiome analyses. The obvious safety concern is the
transmission of an infection from the donor. All donors will be carefully screened for
high-risk exposures and will undergo testing of both blood and stool to ensure that they are
free of infections due to HIV, acute hepatitis A, acute/chronic hepatitis B, hepatitis C,
giardiasis, cryptosporidiosis, and Helicobacter pylori.

Inclusion Criteria:

- Study entry is open to adults (>18 years old) who have had three of more episodes of
Clostridium difficile colitis within the previous 12 months.

Exclusion Criteria:

- Absolute neutrophil count < 500 cells/mm3

- Active infection at other sites (excluding Clostridium difficile) requiring ongoing
antibacterial therapy (antiviral or antifungal therapy is acceptable)

- Current or planned cytotoxic chemotherapy within 14 days of the potential fecal
transplantation date

- Life expectancy <180 days

- Diagnosis of inflammatory bowel disease (e.g. Crohn's or ulcerative colitis)

- Inability to swallow capsules

- Indwelling nasogastric, orogastric, gastrostomy, or jejunostomy tube

- History of partial or total gastrectomy

- Short gut syndrome requiring total parenteral nutrition

- Pregnancy

- Documented intestinal parasite infection without documentation of appropriate
treatment