At this year’s installment of Digestive Diseases Week (DDW), clinicians gathered to discuss current best practices for the use of fecal microbiota transplantation (FMT) to treat recurrent Clostridium difficile infections (CDIs). The American Gastroenterological Association’s (AGA’s) FMT National Registry, which begins enrolling patients this year, will play a crucial role in further elucidating the short- and long-term clinical outcomes associated with FMT.
Considered by many in the medical community to be a potential magic bullet for treating recurrent CDIs, FMT has enjoyed a surge in popularity in recent years despite lingering questions surrounding its effectiveness and safety, with long-term safety being the chief concern of experts. To date, clinical studies have yielded encouraging yet mixed results, with experts stressing the need to collect larger datasets to allow for more robust conclusions, particularly related to the managing of FMT nonresponders and patients with severe/severe-complicated recurrent CDIs. Researchers also must address the current heterogeneity of how FMT is administered, which makes it difficult to compare clinical trials and identify general trends in the data.
The FMT National Registry, which is looking to enroll 4,000 patients across 75 sites in the US and Canada, seeks to answers these questions while simultaneously emphasizing the growing importance of the microbiome in biomedical research. Championed by the AGA Center for Gut Microbiome Research and Education and sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), the registry will follow-up with patients up to 10 years post-FMT and will eventually make data available to researchers upon request. With key stakeholders encompassing professional medical societies (AGA, Infectious Diseases Society of America [IDSA]), federal agencies (FDA, Centers for Disease Control and Prevention [CDC]), stool banks (OpenBiome), and patient advocacy groups, GlobalData expects the FMT National Registry to successfully achieve its goal of collecting an unprecedented amount of data.
While patients suffering from recurrent CDIs stand to benefit most from the FMT National Registry—particularly in the short-term—experts have only begun to scratch the surface on the potential utility of FMT in treating other gastrointestinal (GI) disorders, such as inflammatory bowel disease (IBD) and chronic intestinal pseudo-obstruction (CIPO), as well as non-GI disorders including graft-versus-host-disease (GVHD) and autism. The FDA’s cautious stance towards the clinical application of FMT outside of recurrent CDIs has slowed progress on this front, but experts at DDW are optimistic that more data will be obtained in non-CDI patients in the coming years.
Given that FMT is still in its infancy stages, GlobalData anticipates that the FMT National Registry will be integral in not only helping to identify and refine best practices for its use in treating recurrent CDIs, but also to stoke interest in its potential use in other indications. Ultimately, FMT represents a single, albeit important, step on the roads towards a better understanding of the extraordinarily complex relationship between the microbiome, human health, and disease.