Randomised clinical trial: faecal microbiota transplantation for recurrent Clostridum difficile infection - fresh, or frozen, or lyophilised microbiota from a small pool of healthy donors delivered by colonoscopy

Aliment Pharmacol Ther. 2017 Apr;45(7):899-908. doi: 10.1111/apt.13969. Epub 2017 Feb 21.

Abstract

Background: Faecal microbiota transplantation (FMT) has become routine in managing recurrent C. difficile infection (CDI) refractory to antibiotics.

Aim: To compare clinical response and improvements in colonic microbiota diversity in subjects with recurrent CDI using different donor product.

Methods: Seventy-two subjects with ≥3 bouts of CDI were randomised in a double-blind study to receive fresh, frozen or lyophilised FMT product via colonoscopy from 50 g of stool per treatment from eight healthy donors. Recipients provided stools pre- and 7, 14 and 30 days post-FMT for C. difficile toxin and, in a subset, microbiome composition by 16S rRNA gene profiling.

Results: Overall resolution of CDI was 87% during 2 months of follow-up after FMT. Stool samples before FMT had significantly decreased bacterial diversity with a high proportion of Proteobacteria compared to donors. Cure rates were highest for the group receiving fresh product seen in 25/25 (100%), lowest for the lyophilised product 16/23 (78%; P = 0.022 vs. fresh and 0.255 vs. frozen) and intermediate for frozen product 20/24 (P = 0.233 vs. fresh). Microbial diversity was reconstituted by day 7 in the subjects receiving fresh or frozen product. Improvement in diversity was seen by day 7 in those randomised to lyophilised material with reconstitution by 30 days.

Conclusions: Comparative efficacy in faecal microbiota transplantation was observed in subjects receiving fresh or frozen faecal product from the same donors. The lyophilised product had a slightly lowered efficacy compared with fresh product, but it resembled other treatments in microbial restoration 1 month after faecal microbiota transplantation.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Clostridioides difficile
  • Clostridium Infections / therapy*
  • Colonoscopy
  • Double-Blind Method
  • Fecal Microbiota Transplantation*
  • Feces / microbiology
  • Female
  • Freeze Drying
  • Freezing
  • Humans
  • Male
  • Microbiota / genetics
  • Middle Aged
  • RNA, Ribosomal, 16S / genetics
  • Recurrence
  • Specimen Handling
  • Tissue Donors
  • Young Adult

Substances

  • RNA, Ribosomal, 16S