title: 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.
abstract: Faecal microbiota transplantation (FMT) has become routine in managing recurrent C. difficile infection (CDI) refractory to antibiotics.
  
  
  
  To compare clinical response and improvements in colonic microbiota diversity in subjects with recurrent CDI using different donor product.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
authors.affiliation: University of Texas School of Public Health, Houston, TX, USA.
authors.forename: Z D
authors.initials: ZD
authors.lastname: Jiang
authors.affiliation: Baylor College of Medicine, Houston, TX, USA.
authors.forename: N J
authors.initials: NJ
authors.lastname: Ajami
authors.affiliation: Baylor College of Medicine, Houston, TX, USA.
authors.forename: J F
authors.initials: JF
authors.lastname: Petrosino
authors.affiliation: University of Texas School of Public Health, Houston, TX, USA.
authors.forename: G
authors.initials: G
authors.lastname: Jun
authors.affiliation: University of Texas School of Public Health, Houston, TX, USA.
authors.forename: C L
authors.initials: CL
authors.lastname: Hanis
authors.affiliation: University of Texas School of Public Health, Houston, TX, USA.
authors.forename: M
authors.initials: M
authors.lastname: Shah
authors.affiliation: Baylor St Luke's Medical Center, Houston, TX, USA.
authors.forename: L
authors.initials: L
authors.lastname: Hochman
authors.affiliation: Baylor St Luke's Medical Center, Houston, TX, USA.
authors.forename: V
authors.initials: V
authors.lastname: Ankoma-Sey
authors.affiliation: University of Texas Medical School, Houston, TX, USA.
authors.forename: A W
authors.initials: AW
authors.lastname: DuPont
authors.affiliation: Baylor College of Medicine, Houston, TX, USA.
authors.forename: M C
authors.initials: MC
authors.lastname: Wong
authors.affiliation: Baylor St Luke's Medical Center, Houston, TX, USA.
authors.forename: A
authors.initials: A
authors.lastname: Alexander
authors.affiliation: University of Texas School of Public Health, Houston, TX, USA.
authors.forename: S
authors.initials: S
authors.lastname: Ke
authors.affiliation: University of Texas School of Public Health, Houston, TX, USA.|Baylor College of Medicine, Houston, TX, USA.|Baylor St Luke's Medical Center, Houston, TX, USA.|Kelsey Research Foundation, Houston, TX, USA.
authors.forename: H L
authors.identifier: 0000-0003-1652-7168
authors.initials: HL
authors.lastname: DuPont
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D016360:Clostridioides difficile; D003015:Clostridium Infections / Q000628:therapy*; D003113:Colonoscopy; D004311:Double-Blind Method; D000069467:Fecal Microbiota Transplantation; D005243:Feces / Q000382:microbiology; D005260:Female; D005612:Freeze Drying; D005615:Freezing; D006801:Humans; D008297:Male; D064307:Microbiota / Q000235:genetics; D008875:Middle Aged; D012336:RNA, Ribosomal, 16S / Q000235:genetics; D012008:Recurrence; D013048:Specimen Handling; D014019:Tissue Donors; D055815:Young Adult
chemical_list: D012336:RNA, Ribosomal, 16S