Scaling Safe Access to Fecal Microbiota Transplantation: Past, Present, and Future

Abstract

Key historical barriers to FMT access include regulatory uncertainty, operational complexity of sourcing screened donor material, and logistical challenges of delivering fresh treatment preparations. USBs have demonstrated that FMT can be delivered safely at scale by centralizing donor selection, material processing, and safety monitoring. More evidence is needed to optimize USB methods, including for donor screening, material processing, and novel delivery modalities. USBs have catalyzed broad access to FMT in North America and Europe. Future directions include developing evidence regarding oral preparations, harmonizing guidelines, disseminating best practice protocols, establishing long-term safety profiles, and expanding access to geographic areas of unmet need.

Australian consensus statements for the regulation, production and use of faecal microbiota transplantation in clinical practice

“…Quarantining processed donor material until the results of repeat screening (history, stool testing, blood testing) are available may further reduce the risk of transmissible infectious agents from potential donor infection in the interval between screening timepoints. Current practices are largely directed by expert opinion34 37 38 86 87 and extrapolation from blood donation guidelines 88. However, the relevance of blood donation guidelines is uncertain given clear differences in the risk profile of pathogen transmission via the faecal–oral as opposed to parenteral routes.…”

It’s time to rethink your approach to C diff infection

“…gut microbiome by transplanting donor stool into a recipient. 26 FMT has been shown to be highly effective in 5 randomized clinical trials conducted since 2013, with CDI cure rates between 85% and 94%. 11 This rate of cure is particularly impressive given that the studies only included patients with refractory CDI.…”

Mechanistic Insights in the Success of Fecal Microbiota Transplants for the Treatment of Clostridium difficile Infections

“…Taken together, the data show that for patients suffering from multiple recurrent CDI, FMT is a highly effective treatment ( Ooijevaar et al, 2018 ) and FMT is now indicated in therapeutic guidelines for this group of patients ( McDonald et al, 2018 ). Recommended treatment modalities and FMT procedures have been reviewed elsewhere ( Cammarota et al, 2017 ; Terveer et al, 2017b ; Woodworth et al, 2017 ; Panchal et al, 2018 ).…”