Rode 2021.

Study characteristics
Methods	Open‐label, multicenter randomized controlled trial conducted in Denmark
Participants	Inclusion criteria Aged ≥ 18 years Recurrence of C difficile infection, i.e. diarrhea and a new positive test for C difficile within 90 days after a former episode of CDI Has received ≥ 1 course of either vancomycin (≥ 125 mg 4 times daily for 10 days) or metronidazole (≥ 500 mg 3 times daily for 10 days) Possibly have started oral vancomycin within 7 days prior to inclusion Ability to give informed consent Exclusion criteria Life expectancy < 3 months Allergy to vancomycin Other GI diseases, infections, and conditions with diarrhea or disturbed symptom reporting, such as colectomy Planned concomitant antibiotic treatment for > 14 days after inclusion Severe immune suppression Pregnancy, breastfeeding women, fertile women with no reliable birth control
Interventions	Intervention Frozen–thawed donor feces solution given 36 hours after pretreatment with vancomycin for 1–14 days; n = 34 Route: enema Frequency: 1–3 infusions Weight of stool: 50 g Volume per treatment: 170 mL Donor: healthy relative or unrelated volunteers Comparison Vancomycin 125 mg 4 times daily for 14 days. Participants with ≥ 2 recurrences of CDI were treated with additional 5 weeks of vancomycin taper; n = 31 RBT; 12 bacterial strains suspended in 200 mL isotonic saline given via enema 12 hours after pretreatment with vancomycin for 7–12 days. 3 infusions were given on 3 consecutive days; n = 33 Donor screening Used frozen donor stool from a donor stool bank with extensively tested universal donors recruited from the Danish Blood Donor Corps.
Outcomes	Primary outcome Clinical cure within 90 days after ended treatment. Clinical cure defined as absence of C difficile infection (i.e. absence of diarrhea or diarrhea with a negative C difficile test) Secondary outcome Clinical cure within 180 days after ended treatment Safety outcomes AEs SAEs 180‐day mortality (all‐cause and possibly C difficile‐related mortality)
Notes	Study authors did not comment on the recurrence of a new CDI. Study authors analyzed the primary endpoint on intention‐to‐treat, modified intention‐to‐treat, and per‐protocol basis. We added both intention‐to‐treat and as‐available analysis for primary outcomes to the review. For our analysis, we used the total of the 2 comparison groups as the control. Funding: (quote) "This study was funded by Ministeriet Sundhed Forebyggelse, The Research Council for Naestved/Ringste /Slagelse Hospital, Hvidovre Hospital, The Research fund of the Department of Infectious Disease, Hvidovre Hospital, The Christenson‐Cesons Family Foundation and the Region Sjælland. None of the funders had any influence on designing the study, analysing data or writing the manuscript."