Ferring Pharmaceuticals has had editorial planning involvement, including suggestions of content and topics, as well as proposal of experts for articles. The final educational content was independently developed and approved by the GMFH publishing team and editorial board.
This is the fourth article in a special collection aimed at focusing on the epidemiology, diagnosis and management of C. difficile infection, of relevance to gastroenterologists. See the first article on C. difficile infection prevalence, risk factors and co-occurrence with COVID-19 here, the second article on diagnosis and management of primary and recurrent C. difficile infection here, and the third article on live microbiome-based therapeutics here.
C. difficile infection is dependent on the balance of the intestinal microbiota and incidence is increasing in US and Europe. This opportunistic pathogen is the leading identified cause of hospital diarrhea associated with antibiotic therapy worldwide and is considered an urgent public health threat. It’s been almost 10 years since the first successful clinical trial of fecal microbiota transplantation (FMT) in patients with C. difficile infection (CDI). Back in 2013, that was an abstract therapeutic treatment that received intense suspicion from the side of both clinicians and patients.
How do doctors, patients and caregivers feel about it now? The GMFH editing team connected with Dr. Ben Mullish, clinical lecturer in Gastroenterology and Hepatology, based at Imperial College London, to further discuss the matter. Dr. Mullish has been treating CDI patients with FMT for more than 8 years, and happily shared with us both clinicians’ and patients’ perspective.
How do you and your colleagues feel treating CDI with FMT?
“Treating CDI patients with FMT might sound abstract and bizarre, but it was so effective that within days you could start to see such a huge change in patients’ clinical perspective. That was really impressive!”. Dr. Mullish explained how a treatment with FMT can have an immediate positive impact in patients’ functionality, especially the ones with multiple recurrences, who have been in-and-out the hospital for many months, and who had only gained temporary relief with conventional C. difficile-related antibiotics. He shared the usual concern of clinicians applying a therapy published in a clinical trial, that in real life might not work the same way, emphasizing that “This (i.e. FMT) was the real deal”.
Now, the actual question relates to how you introduce discussion of this therapy to the patient and their caregivers. How does such a conversation usually go?
“When we started this a few years ago, it was a difficult conversation, and a number of people did say no because it was too bizarre for them and too new. Currently, there is a lot more public awareness about the gut microbiota that sets an enthusiasm which allows us to go back to the people and say: look we know the safety of this, we know the effectiveness of this, we know a great deal about optimal administration, we have all this knowledge that we did not have before, and years of experience. So people can buy into the rationale of restoring the balance of their microbiome to treat CDI, even if they are not entirely settled of details.”
Dr Mullish continued, “Patients might have even heard of FMT through television, radio, or read about it, and they can therefore buy into this idea. There is more open-mindedness about it, and there is more awareness about it. Regardless of their background, more and more patients can understand the concepts of bacteria in our gut contributing to our health above those that caused the initial infection, and restoring this balance can mitigate the damage that antibiotics might have caused and reverse disease.”
“Even patients who had a somewhat negative view about FMT at first discussion have had changed their opinion after failing to treat their symptoms with antibiotics.”
Nevertheless, there is still a long way to go until FMT becomes first line treatment for CDI and the actual numbers of people suffering or even dying because of CDI decrease. Although FMT clearly became accepted as a treatment option, quality control, the difficulty of setting up and managing a stool bank in a hospital, and the cost of fecal transplants may still hinder the generalized use of fecal microbiota transplants in clinical practice. Therefore, specific and carefully characterized stool-derived or synthetic fractions are currently being studied as safer treatments than FMT for recurrent C. difficile. Over the past decade, basic, translational and foremost clinical research has increasingly pushed the successful forward movement of the field. That was promisingly highlighted last September 22, 2022, when the Vaccines and Related Biological Products Advisory Committee of the U.S. Food and Drug Administration recommended approval of RBX2660, an investigational microbiota-based live biotherapeutic studied for its potential to reduce recurrence of CDI after antibiotic treatment.
We yet need to see whether the agency will consider the recommendation of the advisory committee, and this promising therapeutic will get in the first-line of CDI treatment.
Taken together, the need for public awareness and continuous research is still profound, so let us all embrace and communicate November as CDI awareness month!
Special thanks to Florine Jiwa, MD, PhD candidate at Imperial College of London and Amsterdam University Medical Centers, for bringing us in contact and interviewing Dr. Ben Mullish.
Coming soon: A new article in the series focusing on the factors associated with C. difficile outcomes and the long-term complications of C. difficile infection. Stay tuned for upcoming news!
References:
van Nood E., Vrieze A., Nieuwdorp M. et al., Duodenal Infusion of Donor Feces for Recurrent Clostridium difficile N Engl J Med. 2013. doi: 10.1056/NEJMoa1205037
