P0238 - Real World Outcomes of Fecal Microbiota-Based Therapies to Prevent Recurrent Clostridioides Difficile Infections up to 24 Weeks

Larry Nguyen, MD¹, Jessica R. Allegretti, MD, MPH, FACG², Grace Hardwick, ³, Jordan Axelrad, MD, MPH^1
1NYU Grossman School of Medicine, New York, NY; ²Brigham and Women’s Hospital, Harvard Medical School, Boston, MA; ³Brigham and Women’s Hospital, Boston, MA

Introduction: Microbial therapies are emerging as effective strategies for preventing recurrent Clostridioides difficile infection (rCDI). Fecal microbiota, live-jslm, the first rectally administered microbiota live product, and Fecal microbiota spores, live-brpk, the first orally administered fecal microbiota product were recently FDA approved for the prevention of rCDI. Here, we report a real-world efficacy analyzes of these novel microbial therapies in preventing rCDI.

Methods: Adults with rCDI treated with Fecal microbiota, live-jslm, Fecal microbiota spores, live-brpk, or conventional fecal microbiota transplant (FMT) were identified between October 2014 and May 2024. All Fecal microbiota, live-jslm and FMT were administered via colonoscopy. Recurrence of CDI was defined by relapse of diarrheal symptoms, confirmatory stool testing, and subsequent standard-of-care antibiotic treatment. Treatment success rate and clinical cure rate was defined as absence of rCDI for 8- and 24-weeks post-treatment, respectfully. Efficacy was stratified based on age, standard of care antibiotic, duration of prior antibiotic treatment, number of prior CDI episodes and presence of inflammatory bowel disease (IBD).

Results: We identified 22 patients who received Fecal microbiota, live-jslm, 19 received Fecal microbiota spores, live-brpk, and 90 received conventional FMT for rCDI prevention. Treatment success in preventing rCDI at week 8 was 100%, 89.5%, and 72.2% for Fecal microbiota, live-jslm, Fecal microbiota spores, live-brpk, and conventional FMT, respectively (Figure; p < 0.05, p = 0.13). Clinical cure rate in preventing rCDI at week 24 was 93.8%, 66.7%, and 61.1% for Fecal microbiota, live-jslm, Fecal microbiota spores, live-brpk, and conventional FMT, respectively (p = 0.03, p = 0.71). Stratifying efficacy by all covariates up to 24 weeks demonstrated the equivalent efficacy of Fecal microbiota, live-jslm and Fecal microbiota spores, live-brpk compared to conventional FMT (Table). No serious treatment-related adverse events were reported in this study.

Discussion: Our real-world data demonstrates the efficacy of these novel fecal microbiota-based therapies in preventing rCDI. Fecal microbiota, live-jslm demonstrated superior overall efficacy compared to conventional FMT in preventing rCDI up to 24 weeks post-treatment. Further analysis with larger sample size and combination with other therapies are required to determine the most efficient strategy to prevent rCDI.



Disclosures:


Larry Nguyen, MD¹, Jessica R. Allegretti, MD, MPH, FACG², Grace Hardwick, ³, Jordan Axelrad, MD, MPH¹. P0238 - Real World Outcomes of Fecal Microbiota-Based Therapies to Prevent Recurrent <i>Clostridioides Difficile</i> Infections up to 24 Weeks, ACG 2024 Annual Scientific Meeting Abstracts. Philadelphia, PA: American College of Gastroenterology.