4 Efficacy

4 Efficacy

This section describes efficacy outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the interventional procedures guidance overview.

4.1 A trial of 43 patients treated by faecal transplant versus vancomycin with a bowel lavage versus vancomycin only, reported a primary cure rate of 81% (13/16), 23% (3/13) and 31% (4/13) respectively at 10‑week follow-up. The faecal transplant group had statistically significantly higher cure rates compared against the vancomycin with bowel lavage and vancomycin-only groups (p<0.001). Patients for whom an initial faecal transplant failed (n=3) had another transplant; 66% (2/3) of these patients were cured, resulting in an overall cure rate of 94% (15/16).

4.2 A systematic review of 25 studies, which included 289 patients with refractory Clostridium difficile infection treated by a faecal transplant, reported complete resolution of symptoms in 91% of patients at a mean follow-up of 12.6 months.

4.3 A non-randomised comparative study of 43 patients treated by faecal transplants using fresh stool from a related donor, transplants using fresh stool from an unrelated donor or transplants using frozen stool from an unrelated donor, reported resolution of symptoms with negative stool samples in 70% (7/10), 92% (11/12) and 90% (19/21) of patients respectively at 12‑month follow-up. There were no statistically significant differences between the success rates of related and unrelated donor faeces or between the success rates of fresh and frozen faeces.

4.4 The randomised controlled trial of 43 patients treated by a faecal transplant, vancomycin with bowel lavage, or vancomycin only, reported relapses within 5 weeks of the start of therapy in 6% (1/16), 54% (7/13) and 62% (8/13) of patients respectively.

4.5 The systematic review of 25 studies reported that 2.4% (7/289) of patients had a relapse between 29 days and 4 years after faecal microbiota transplant.

4.6 The specialist advisers listed key efficacy outcomes as cure of infection and no further relapses of C. difficile infection.

  • National Institute for Health and Care Excellence (NICE)