The US Food and Drug Administration (FDA) approved the first faecal microbiota-derived product late last year under the name Rebyota (Ferring Pharmaceuticals Inc, Roseville, US) to treat patients with recurrent C. difficile infection. Infection by this bacterium is the leading cause of antibiotic-associated infectious diarrhoea in hospitalised patients worldwide. Despite the effectiveness of antibiotic treatment, the high rate of infection recurrence in patients with previous episodes of C. difficile and disease-associated complications remain problematic; as does the increase in costs derived from hospitalisation.
For some years now, faecal microbiota transplantation (FMT) has been the treatment of choice included in clinical guidelines for the prevention of recurrent C. difficile infection. There are hospital centres that perform it in Spain, but the treatment is subject to obtaining valid stool samples from healthy donors, which makes its implementation difficult. Access to treatments prepared with quality guarantees would make it easier for patients to receive it, regardless of the hospital centre they are at.
Rebyota is defined as a faecal microbiota product obtained from qualified donors who have to pass the screening, consisting of questionnaires and an exhaustive blood and faeces analysis. The treatment has been evaluated in numerous clinical trials in the United States and Canada. It has shown high efficacy in these trials with very few adverse effects (less than 3%). Among them are discomfort, abdominal pain, diarrhoea and nausea. The product is administered rectally 24-72 hours after completing antibiotic treatment. It has to be kept at a temperature of -80 °C, or in a fridge for 5 days.
Using a faecal microbiota-derived product in patients with C. difficile reinfections after antibiotic prescription is the start of a new effective treatment pathway for them. Approval of this product by the FDA opens up the commercialisation of industrially produced FMT treatment accessible to patients in the healthcare setting. Also, the fact that such an important regulatory agency supports this FMT treatment may make it easier for regulation and favourable advances in countries where this treatment is not yet established, while opening up the option of implementing it in hospital centres.
Author:
Dr. Andrea Aira Gómez, microbiologist and postdoctoral researcher at the Microbiology Unit, Hospital Clínic, Barcelona.
