| Outcomes |
Primary outcomes
rCDI (definite or probable) or death. Definite defined as any of the following: new onset of > 3 loose or watery stools in 24 hours for 2 consecutive days; other clinical symptoms including ileus, toxic mega colon, or colectomy; plus laboratory confirmation of C difficile from a stool specimen. Probable recurrence defined as the same clinical manifestations as above, but without laboratory confirmation of C difficile (stool test not sent, negative result, or uninterpretable result) (time frame: within 56 days of randomization)
Secondary outcome
rCDI (definite or possible), or death (time frame: within 6 months of randomization) Quality of life. Investigators will use a brief assessment of both overall and GI health status, using a previously validated instrument (time frame: 56 days from randomization) Number of CDI recurrences (time frame: within 6 months of randomization) Diarrhea that is negative for C difficile by EIA toxin test and PCR. This is similar to probable recurrent CDI, but includes only episodes of diarrhea that test negative for C difficile by EIA toxin test and PCR, not episodes that are not tested or are uninterpretable (time frame: within 56 days of randomization). Multiple related symptoms. An assessment for non‐diarrheal manifestations of CDI such as abdominal pain, urgency, and fecal incontinence will be performed (time frame: within 6 months of randomization) Definite recurrent CDI. Definite recurrence defined as any of the following: new onset of > 3 loose or watery stools in 24 hours for 2 consecutive days; other clinical symptoms including ileus, toxic mega colon, or colectomy; plus laboratory confirmation of C difficile from a stool specimen (time frame: within 56 days of randomization) Possible recurrent CDI. Defined as the same clinical manifestations as definite recurrent CDI, but without laboratory confirmation of C difficile (stool test not sent, negative result, or uninterpretable result) (time frame: within 56 days of randomization) Death (time frame: within 56 days of randomization) Diarrhea that is negative for C difficile by EIA toxin testing but positive by PCR. This is similar to possible recurrent CDI but includes only episodes of diarrhea that test negative for C difficile by EIA toxin test, not episodes that are not tested or are uninterpretable (time frame: within 56 days of randomization)
Other outcome
AEs and SAEs (time frame: within 6 months of randomization)
Safety outcomes
SAEs, with a focus on hospitalization (new or prolonged), and all‐cause mortality AEs that may be related to FMT treatment including AEs that investigators consider related/possibly related to the study treatment and all AEs that occur within 14 days of study treatment (since an aggregate analysis of events temporally linked to treatment could show a causal relationship when compared to placebo) Infectious transmissions that are plausibly linked to FMT treatment Development of new conditions theoretically linked to alterations in gut microbiota
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