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

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.

The use of faecal microbiota transplant as treatment for recurrent or refractoryClostridium difficileinfection and other potential indications: joint British Society of Gastroenterology (BSG) and Healthcare Infection Society (HIS) guidelines

“…One double blind, randomised study concluded that enema-administered frozen FMT (n=91) was non-inferior for clinical resolution of diarrhoea to fresh FMT (n=87) for the treatment of recurrent or refractory CDI16 (with frozen FMT in this study stored at −20°C for up to 30 days). A further randomised study demonstrated statistically comparable remission rates for recurrent CDI with fresh or frozen FMT delivered colonoscopically (n=25/25 vs 20/24 respectively, P=0.233) (using frozen FMT stored at −80°C for up to 6 months) 13. These data support the findings of earlier small observational studies 35 41.…”

“…Efficacy is similar whether FMT is fresh or frozen, but modestly reduced when using a lyophilised FMT product 13. Colonoscopic delivery of donor FMT into the ileum or caecum was associated with a 91% cure rate for recurrent CDI 14.…”

“…One randomised study reported the presence of IBD in 10/17 (59%) FMT recipients,16 and there did not appear to be any significant difference in primary outcome measures in this group. Another randomised trial included 14/72 (33%) patients with IBD and reported clinical cure of CDI in 12/14 (86%) of these patients 13. This study also included 64/72 (89%) patients with cardiac, respiratory, renal, CNS or multiorgan system comorbidities13; however, outcomes were not stratified according to comorbidity.…”

“…Another randomised trial included 14/72 (33%) patients with IBD and reported clinical cure of CDI in 12/14 (86%) of these patients 13. This study also included 64/72 (89%) patients with cardiac, respiratory, renal, CNS or multiorgan system comorbidities13; however, outcomes were not stratified according to comorbidity. Kelly and coauthors60 reported an overall cure rate of 94% in a subset of CDI patients with IBD.…”

Complementary and Alternative Medicine Strategies for Therapeutic Gut Microbiota Modulation in Inflammatory Bowel Disease and their Next-Generation Approaches

“…A recent study comparing lyophilized FMT product with fresh or frozen products (using same donors) revealed lyophilized product had slightly lower efficacy (vs fresh), whereas no difference between fresh and frozen fecal product was identified [410]. The hygiene hypothesis, one of the longest standing theoretical frameworks associated with the pathogenesis of IBD [4, 411–414], also happens to underpin the single most unexplored aspects of FMT administration, namely optimum timing for microbiota modulation.…”