Refractory C diff: multiple fecal transplants 100% effective in open-label trial

  • Ianiro G & al.
  • Aliment Pharmacol Ther
  • 30/05/2018

  • Jenny Blair, MD
  • Clinical Essentials
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Takeaway

  • Repeated fecal microbiota transplantation (FMT) along with vancomycin (Vancocin) for refractory Clostridioides difficile infection (CDI) achieved 100% cure vs single transplant in this randomized controlled trial.
  • Patients with pseudomembranous colitis also responded well to multiple FMT.

Why this matters

  • Single FMT infusions for severe CDI and pseudomembranous colitis may be effective, but recurrences often follow.
  • Small studies suggest high cure rates for severe or recurrent CDI with repeated FMT infusions.

Key results

  • Single- vs multiple-FMT protocol:
    • Cure: 75% vs 100%, in both per-protocol and intention-to-treat analyses (P=.01).
    • No serious adverse events.
  • 7 patients not initially cured with a single infusion had pseudomembranous colitis, and 4 had severe-complicated CDI.
  • All were eventually cured with repeated off-protocol FMT.

Study design

  • Open-label, randomized controlled trial, single center in Rome.
  • 56 adults with severe CDI refractory to antibiotics randomly assigned to:
    • Single FMT, then subsequent 14-day vancomycin course, vs
    • ≥2 FMTs, repeated every 3 days among subgroup with pseudomembranous colitis until pseudomembrane resolved, with concomitant 14-day vancomycin course.
  • Outcome: clinical cure of refractory CDI (improvement within 1 week of FMT, diarrhea resolved by 8 weeks).
  • Funding: Not disclosed; authors report no personal or funding interests.

Limitations

  • Small unblinded trial.