Hota 2017.

Study characteristics
Methods	Single‐site, open‐label, randomized controlled trial conducted in Canada
Participants	Inclusion criteria Aged ≥ 18 years History of ≥ 2 episodes of laboratory (C difficile toxin EIA or PCR) or pathology‐confirmed CDI Received ≥ 1 course of oral vancomycin (minimum 10 days of 500 mg total daily dose) Having symptoms correlating with CDI infection that were self‐reported and confirmed by study physicians to meet standard epidemiologic definitions of diarrhea Exclusion criteria Neutropenia, graft versus host disease or other severe immunocompromised states CDI requiring ICU admission Active, severe colitis unresponsive to oral vancomycin Hypersensitivity or intolerance to oral vancomycin Chronic GI diseases that may cause diarrhea Planned therapy in the next 120 days that may cause diarrhea (e.g. chemotherapy) or planned surgery requiring perioperative antibiotics within 120 days Pregnancy Significant bleeding disorder Inability to tolerate FMT procedure
Interventions	Intervention Fresh donor feces solution enema given 48 hours after pretreatment with vancomycin for 14 days; n = 16 Route: enema Frequency: single Weight of stool: 50 g Volume per treatment: 500 mL Donor: healthy relative or unrelated volunteers Comparison Vancomycin 14 days of standard dosing (125 mg orally every 6 hours) followed by a taper over 4 weeks; n = 14 Donor screening Healthy adult aged ≥ 18 years screened using a self‐screening questionnaire of behaviors associated with risk for blood‐borne pathogens, study physician assessment, and blood and stool testing for potentially transmissible infections and screening were developed in consultation with Health Canada.
Outcomes	Primary outcome Recurrence of symptomatic, laboratory‐confirmed CDI within 120 days of the intervention Secondary outcomes Recurrence of CDI symptoms within 14 and 120 days (not laboratory‐confirmed) Recurrence of CDI within 120 days of crossover Days of diarrhea in the 120 days of follow‐up CDI requiring hospital admission Safety outcomes Solicited AEs at days 4 and 7 Unsolicited AEs within 14 days of interventions SAEs throughout follow‐up Mortality attributable to CDI during follow‐up All‐cause mortality throughout follow‐up
Notes	Recurrence was described as symptomatic, laboratory‐confirmed CDI within 120 days of the intervention and this is different from recurrence of new CDI per our protocol. The study authors performed a per‐protocol analysis. We created an intention‐to‐treat analysis by considering all the participants who were randomized to FMT and vancomycin group. We also performed a sensitivity analysis on an as‐available basis. The authors reported lack of resolution of rCDI and our primary outcome was resolution of rCDI. We subtracted the ones whose rCDI did not resolve from the total randomized to obtain the participants with resolution of rCDI. Funding for the study: (quote) "This work was supported by the Physicians Services Incorporated Foundation (grant number PSI 10‐2021); Public Health Ontario; University of Toronto Department of Medicine Integrating Challenge Grant; University Health Network; and Sinai Health System (in kind)."