Faecal microbiota transplantation for recurrent Clostridiodes difficile infection & its global regulatory landscape.

Abstract

For recurrent Clostridioides difficile infection (rCDI), faecal microbiota transplantation (FMT) is a known and useful treatment that involves introducing faeces from a healthy individual into the digestive tract of a diseased person. Clostridioides difficile is a substantial global health burden due to its high death rate in elderly populations and its ability to produce colitis and diarrhoea. Despite being used since millennia, FMT has recently become more well-known and two FMT products, namely Vowst and Rebyota also received FDA approval. Different nations address regulation in different ways. For instance, FMT is regulated as a drug in the US but is classified as a medicinal product in the UK. The regulatory frameworks among various European countries also vary; a working group, citing FMT as a transplant product, has requested for complete regulation. There are other classifications as well; in Australia, FMT is categorised as a biologic by the Therapeutic Goods Administration. Research indicates that FMT is beneficial in various illnesses, apart from CDI, due to its impact on the gut flora. Challenges include insufficient FMT product characterisation, ethical concerns, and limited hospital accessibility. There are still issues with data accessibility, security, and privacy, especially considering FMT's commercialisation. The official FMT recommendation for recurrent CDI is emphasised from the perspective of public health, with the argument that early implementation could limit antibiotic overuse and prevent antibiotic resistance. Initiatives like the Universal Stool Bank concept aim to streamline donor selection and distribution procedures to minimise operational restrictions.