Data was also obtained on the stool donor, including the results
of screening tests. Finally, data was collected on the preparation
(pretreatment) of the stool mixture, on the FMT procedure itself,
and on clinical course and laboratory follow up test results after the
FMT. Clinical resolution or clinical relapse was determined by the
post FMT clinical course, as reported by the patient and recorded in
the medical record, during the first 60 days following transplantation.
For the purpose of data management and analysis, each
separate FMT treatment was defined as one FMT course. Study
outcomes included primary and secondary FMT cure rates. The
primary cure rate was defined as resolution of diarrhea without
recurrence within 60 days of FMT. The secondary cure rate was
calculated by adding patients who had failed FMT, but subsequently
resolved their diarrhea after an additional course of oral
vancomycin.