Icahn School of Medicine at Mount Sinai New York, NY
Gassan Kassim, MD1, Ryan Ungaro, MD1, Ari M. Grinspan, MD2, David B. Sachar, MD, MACG1, Jean-Frederic Colombel1, Eyal Klang, MD1; 1Icahn School of Medicine at Mount Sinai, New York, NY; 2Mount Sinai Hospital, New York, NY
Introduction: First described in 1958 as a possible treatment modality for pseudomembranous enterocolitis, FMT has become part of the treatment guidelines for recurrent Clostridioides difficile (C diff) infections and is currently being explored in multiple conditions. This study aimed to investigate registered clinical trials of FMT in gastrointestinal and various non-GI conditions. Methods: We analyzed the available ClinicalTrials.gov registry, a web-based resource maintained by the National Library of Medicine (NLM) at the National Institutes of Health (NIH) for registering clinical trials. Data retrieval was performed on 5/25/2020. We searched for all trials including the terms microbiome or microbiota. The database was downloaded and analyzed. Trials dealing with FMT were collected. Official title, summary, detailed description, and primary outcome of every trial were reviewed. Trials were then stratified by the discipline and by disease or condition. Results: We retrieved 258 FMT clinical trials. Of those, 171/258 (66.3%) were related to GI conditions. 87/258 (33.7%) were related to non-GI conditions. In GI, the most studied condition was C diff colitis with 68/184 trials (40.0%) followed by inflammatory bowel disease (IBD) with 47/184 trials (25.5%) and irritable bowel syndrome (IBS) with 14/184 trials (7.6%). In the non-GI group, we identified 12 different disciplines (Figure 1) with oncology and infectious diseases being the most common (24 and 19 trials respectively). Table 1 details the conditions studied in each discipline. The most studied condition was infections related to multidrug resistant organisms such as carbapenem-resistant Enterobacteriaceae (CRE) and vancomycin-resistant Enterococcus (VRE) (17 trials) Discussion: FMT is a major topic of clinical trials not only in GI but also in multiple non-GI conditions. This underscores the need for improvement of efficacy and safety of FMT through deep analysis of components of the microbiome responsible for its therapeutic effects.
Figure 1: FMT Clinical trials in various non-GI disciplines
Table 1: Detailed description of FMT clinical trials stratified by medical disciplines and conditions
Disclosures: Gassan Kassim indicated no relevant financial relationships. Ryan Ungaro indicated no relevant financial relationships. Ari Grinspan indicated no relevant financial relationships. David Sachar indicated no relevant financial relationships. Jean-Frederic Colombel indicated no relevant financial relationships. Eyal Klang indicated no relevant financial relationships.