fecal transplant in C. diff

The patient has severe CDI. While CDI has been known for many years as a potentially fatal change in gut flora (leading to the dominance of C difficile followed by release of enterotoxins), increasing attention to the microbiome in health and illness has generated substantial interest in interventions designed to restore a “healthy” microbiome. Despite substantial interest in the microbiome, this remains an area of considerable variation and uncertainty. As opposed to a traditional pharmaceutical agent, which is purified and reproduced to identical specifications each time, fecal microbiota are obtained from healthy donors. In the early years of fecal microbiota transplantation (FMT), patients’ housemates might donate feces. More recently, companies identify a stable group of donors (historically employees or graduate students, although this is changing). In late 2022, FDA approved fecal microbiota, live-jslm (Rebyota™), administered rectally to prevent recurrent CDI. The data used to support registration demonstrated an increase in success at preventing CDI recurrence of 70.6% vs. 57.5% in the placebo group (absolute risk reduction [ARR] 13%). In early 2023, FDA approved fecal microbiota spores, live-brpk (VOWST™), administered orally to prevent recurrent CDI. This was based on registration trials suggesting a recurrence rate (through 8 weeks) of 12.4% vs. 39.8% among placebo-assigned patients (ARR 27.4%). The fecal microbiota, live-jslm product contains polyethylene glycol (PEG)3350 and thus should not be administered to a patient with known anaphylaxis to PEG3350. Given the inherent variability of fecal microbiota, transmission of multidrug-resistant organisms has been documented, owing to a common lack of consistent standards for screening donated feces. FMT can be administered in multiple ways—swallowing pills, upper endoscopy, through a nasoenteric tube, or by colonoscopy or retention enema directly in the colon (fecal microbiota, live-jslm is administered as a rectal enema). While it is possible that these approaches have variable cost safety profiles, specific guidance is not available for the preferred route of administration for non-approved FMT and should likely be made on a case-by-case basis. While the best evidence supports relapse prevention with FMT, multiple case series now report the successful use of FMT to avoid emergent colectomy in patients who meet criteria for severe CDI. How and whether to attempt emergent FMT is an area of open debate. Ongoing studies—including technical innovations and clinical trials—of FMT in multiple arenas are attempting to improve the evidence basis.1234

Footnotes

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  2. Alukal J, Dutta SK, Surapaneni BK, et al. Safety and efficacy of fecal microbiota transplant in 9 critically ill patients with severe and complicated Clostridium difficile infection with impending colectomy. J Dig Dis. 2019;20(6):301-307. PubMed ↩

  3. Fischer M, Sipe B, Cheng YW, et al. Fecal microbiota transplant in severe and severe-complicated Clostridium difficile: a promising treatment approach. Gut Microbes. 2017;8(3):289-302. PubMed ↩

  4. McDonald LC, Gerding DN, Johnson S, et al. Clinical practice guidelines for Clostridium difficile infection in adults and children: 2017 update by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA). Clin Infect Dis. 2018;66(7):e1-e48. PubMed ↩