Results from England’s first licensed FMT stool bank are now available.
The prevalence and poor treatment outcomes associated with recurrent Clostridioides difficile (C diff) infections have encouraged the exploration of alternatives to the current standard of antibiotic use. One such alternative is fecal microbiota transplantation (FMT).
The investigators of a new study, published in EClinicalMedicine, have shared the results of England’s first licensed FMT stool bank, which provided FMT to patients throughout the national health service (NHS). In 78% of cases, the patient's diarrhea stopped and did not return in the 90 days after treatment.
The FMT bank was established at the University of Birmingham as the Microbiome Treatment Centre. Prior to the establishment of the bank, access to FMT was considerably limited in the United Kingdom. Only about 28% (36 of 130) of hospitals in a UK survey reported using FMT for C diff.
The Microbiome Treatment Centre worked under the production guidelines of the Human Tissue Authority (HTA) and then the Medicines and Healthcare Products Regulatory Agency (MHRA) to provide free FMT procedures to NHS patients. The study team published outcome data for the first 124 patients treated under HTA approval as well as their methodological steps for ensuring production which met regulatory standards.
Out of the 124 patients, 78 (63%) were women and the median age was 78.5 years. Most patients received FMT via nasogastric tube.
There were 71 cases of C diff recurrence and 53 refractory cases, respectively. There were 6 patients who received a second FMT due to recurrence.
In 118 eligible cases, clinical response to 1 FMT procedure was 83.9%. Clinical response was higher in the recurrence group compared to the refractory case group, at 91% and 73%, respectively. Response without disease recurrence was observed in 78.2% of those alive at day 90.
There were 2 patients who died within 7 days of FMT treatment and 2 cases of bacteremia post-FMT. The first patient died of a perforated viscus and uncontrolled C diff despite the treatment. The second patient died of underlying bowel cancer.
The first patient with bacteremia developed fever within a few hours of the FMT procedure, and blood cultures grew Escherichia coli. In the second bacteremia case, blood cultures grew Serratia marcescens. FMT reference samples for the second case did not grow Serratia marcescens. Both bacteremia cases were resolved with antibiotic treatment.
In presenting their positive outcomes, the study authors also emphasized that they had developed a framework for meeting safe production requirements in a complex regulatory environment.
“We have developed a closed fully disposable system for the preparation of FMT in a class two microbiological safety which minimizes the risk of external microbial contamination,” the study authors wrote.
There were high profile stories of patient complications post-FMT last year. When an ESBL- E coli-contaminated capsule led to a patient death, the fate of FMT seemed in question. But it appears from the Microbiome Centre’s work that there could be a bright future for the treatment.
"This work has turned an unregulated potentially dangerous method of faecal transplantation into a national service providing rapid, safe regulated, life-saving treatment for a serious disease affecting thousands of patients in the UK,” said study author Peter Hawkey, PhD, professor of clinical and public health bacteriology at the University of Birmingham's Institute of Microbiology and Infection in a press release.