Randomised clinical trial: a 12-strain bacterial mixture versus faecal microbiota transplantation versus vancomycin for recurrent Clostridioides difficile infections

Anne Abildtrup Rode, Mahtab Chehri, Laura Rindom Krogsgaard, Kristine Klysner Heno, Anna Tølbøll Svendsen, Iben Ribberholt, Morten Helms, Jørgen Engberg, Kristian Schønning, Michael Tvede, Christian Østergaard Andersen, Ulrich Stab Jensen, Andreas Munk Petersen, Peter Bytzer

Publikation: Bidrag til tidsskriftArtikelForskningpeer review

Abstract

BACKGROUND: A defined bacterial mixture could be a safer alternative to faecal microbiota transplantation (FMT).

AIMS: To compare the efficacy of a 12-strain mixture termed rectal bacteriotherapy with either FMT or vancomycin for recurrent Clostridioides difficile infection (CDI) in an open-label 3-arm randomised controlled trial.

METHODS: We screened all individuals positive for C difficile from May 2017 to March 2019. Persons with laboratory-confirmed recurrent CDI were included. Before FMT and rectal bacteriotherapy, we pre-treated with vancomycin for 7-14 days. Rectal bacteriotherapy was applied by enema on three consecutive days and FMT by enema once with possible repetition for two to three infusions within 14 days. The vancomycin group was treated for 14 days with additional five weeks of tapering for multiple recurrences. The primary outcome was clinical cure within 90 days. A secondary outcome was 180-day all-cause mortality.

RESULTS: Participants in the FMT group (n = 34) were cured more often than participants receiving vancomycin (n = 31), 76% vs 45% (OR 3.9 (1.4-11.4), P < 0.01) or rectal bacteriotherapy (n = 31), 76% vs 52% (OR 3.0 (1.1-8.8), P = 0.04). Rectal bacteriotherapy and vancomycin performed similarly (P = 0.61). The mortality rate was 6% in the FMT group, 13% in the bacteriotherapy group and 23% in the vancomycin group. FMT tended to reduce mortality compared with vancomycin, OR 0.2 (0.04-1.12), P = 0.07.

CONCLUSIONS: Rectal bacteriotherapy appears as effective as vancomycin but less effective than 1-3 FMTs. FMT by enema with 1-3 infusions is superior to vancomycin for treating recurrent C difficile infections and might reduce mortality.

OriginalsprogEngelsk
Sider (fra-til)999-1009
Antal sider11
TidsskriftAlimentary Pharmacology and Therapeutics
Vol/bind53
Udgave nummer9
Tidlig onlinedato10 mar. 2021
DOI
StatusUdgivet - maj 2021

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© 2021 John Wiley & Sons Ltd.

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