Faecal microbiota transplant for recurrent Clostridioides difficile infection

2.1 Faecal microbiota transplant (FMT) aims to restore a healthy gut microbiome in people who have recurrent or refractory Clostridioides difficile infections. It involves transferring intestinal bacteria and other microorganisms from healthy donor faeces into the gut of the recipient.

2.2 FMT can be used as a fresh or frozen preparation or in capsule form. It can be given via a lower gastrointestinal route (rectal enema, colonoscopy or flexible sigmoidoscopy), upper gastrointestinal route (using a nasogastric tube, nasoduodenal tube or nasojejunal tube) or via oral capsules. British Society of Gastroenterology and Healthcare Infection Society guidelines recommend a short course of antibiotics before transplantation, with a minimum washout period of 24 hours between the last dose of antibiotic and treatment with FMT. Bowel lavage is also recommended before FMT if it's given via lower gastrointestinal routes.

2.3 FMT must be manufactured in accordance with Medicines and Healthcare products Regulatory Agency (MHRA) guidance for human medicines regulation. When FMT is supplied on a named patient basis, within a single organisation, a pharmacy exemption may be used, subject to ensuring proper governance and traceability. Before establishing an FMT service, NHS centres are legally required to seek advice from the MHRA and, if necessary, obtain licences to process, distribute and carry out FMT. A strict donor screening programme should also be in place for FMT in line with the British Society of Gastroenterology and Healthcare Infection Society guidelines. An FMT service should be delivered by a multidisciplinary team.

2.4 First-line treatment for a C. difficile infection involves rehydration and antibiotic treatment. Some people have recurrent, relapsing, or refractory C. difficile infections and need further courses of antibiotics. NICE's guideline on antimicrobial prescribing for C. difficile infection recommends antibiotics for first and further C. difficile infections, and provides guidelines on antibiotic, dosage and course length. It also recommends considering FMT for a recurrent episode of C. difficile infection in adults who have had 2 or more previous episodes. NICE's interventional procedures guidance on FMT for recurrent C. difficile infection says that current evidence on the efficacy and safety of FMT for recurrent C. difficile infection is adequate to support the use of this procedure provided normal arrangements are in place for clinical governance, consent and audit. It also says that clinicians should ensure that a confidential record is kept of the donor and recipient of each FMT.

2.5 The aim of the procedure is to treat the infection with transplanted gut microbiota instead of prescribing further courses of antibiotics.

2.6 The cost of frozen FMT material is £850 per 50 ml or £1,700 for 150 ml. Including transportation and MHRA licensing, the cost is up to £1,300 per 50 ml (£2,600 for 150 ml). Oral capsules are likely to cost between £500 and £600, based on expert opinion. Additional costs include staff time, procedural costs, additional drugs given as part of the procedure and pretreatment short-course antibiotics.