Fecal Microbiota Transplant (FMT) for Relapsing C. Difficile Infection in Adults and Children Using a Frozen Inoculum

Fecal microbiota transplantation (FMT) is the reconstitution of normal flora by a "stool
transplant" from a healthy individual to a C. difficile-infected recipient, and has long
been a successful approach to recurrent/refractory C. difficile. The purpose of this
project is to generate a frozen FMT inoculum from well-screened healthy volunteer donors
which can be used repeatedly, particularly in those who do not have a healthy intimate
partner or other related donor. Delivery of FMT has been performed colonoscopically, by
fecal retention enema, or by the nasogastric route. This study will evaluate the safety and
secondarily the efficacy of a frozen inoculum administered by nasogastric tube vs
administered by colonoscope.

Subjects with recurrent/relapsing C. difficile infection (10 per group) will receive FMT via
either:

- colonoscopy

- NGT

The primary endpoint is assessment of safety as measured by clinical events (GI, procedural,
systemic). Efficacy will be defined as a resolution of diarrhea off antibiotics for C.
difficile, in the absence of a need for OTHER systemic antibiotics, i.e. resumption of a
normal bowel status for the individual. Secondary efficacy endpoints include weight,
subjective well-being and relative clinical improvement per standardized questionnaire, and
subject qualitative assessment of, and satisfaction with, the transplant procedures.
Subjects will be monitored for clinical safety by history and standard exams and the
follow-up questionnaire as well as followed closely by phone and in person.