EUCTR2015‐003062‐82‐DK.

Study name	Rectal enema with a mix of gut bacteria, rectal enema with fecal material from a healthy donor or oral given vancomycin for the treatment of patients with recurrent diarrhea caused by infection with the bacteria Clostridium Difficile
Methods	Randomized controlled trial (not blinded)
Participants	Adults aged ≥ 18 years
Interventions	Intervention: FMT Participants were pretreated with oral vancomycin 125 mg 4 times a day for 7–14 days. This was discontinued 36 hours prior to FMT. Frozen donor stool from a donor stool bank was administered by rectal enema once, but with a possibility to repeat it up to twice within 14 days after the first infusion. The indication for repetition was ongoing or new‐onset diarrhea (≥ 3 loose or liquid stools per day), as judged by a trial physician, without new testing for C difficile. They used a different donor when repeating FMTs. Control 1: RBT The standardized laboratory‐based bacterial mixture used for RBT consisted of 12 bacterial strains suspended in 200 mL isotonic saline with concentrations of 5 × 1010 bacteria of each strain. Included strains: Escherichia coli MT‐1108‐1, E coli MT‐1109, Enterococcus cassiliflavus, Enterococcus gallinarum, Bacteroides thetaiotaomicron, Bacteroides ovatus, Bacteroides vulgatus, Clostridium bifermentans, C innocuum, Coprobacillus cateniformis, LactobacilIus rhamnosus, and LactobacilIus gasserii. Participants were pretreated with oral vancomycin 125 mg 4 times a day for 7–14 days. This was discontinued 12 hours prior to RBT. RBT was administered by rectal enema with 3 infusions on 3 consecutive days for all participants in this group. Control 2: oral vancomycin All participants in the vancomycin group received monotherapy with oral capsule vancomycin 125 mg 4 times daily for 14 days. Furthermore, participants with ≥ 2 recurrences of CDI were treated with an additional 5 weeks of tapering as recommended in guidelines. The tapering regimen included oral vancomycin 125 mg twice daily for 1 week, 125 mg once daily for 1 week, 125 mg every other day for 1 week, and 125 mg every third day for 2 weeks.
Outcomes	Primary outcome Clinical cure Secondary outcomes 180‐day mortality Non‐SAEs SAEs
Starting date	1 May 2017
Contact information	Clinical Trial Information, Department of Medicine, Zealand University Hospital, Køge, Denmark, +45 23345235, aala@regionsjaelland.dk
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