[BONUS] S1E10 - The Scoop on Poop! Fecal Microbiota Therapy for Reducing Recurrence of CDiff Infections

Welcome to What’s it Worth - a BONUS episode! Join your host Dr. Diana Langworthy and a come-back by P4 student co-host Garrison Griest as we get the scoop on poop! Our expert guest for this episode is Dr. Jen Ross, Antimicrobial Stewardship Clinical Pharmacist at M Health Fairview East and West Bank Hospitals. We're discussing a trial that evaluated the efficacy of a new orally administered fecal microbiota transplant capsule - SER-109. 

This episode coincides with a Journal Club assignment that students in my Evidence Based Practice course completed last week - Hello PHAR6782 Students! Great work on your first official Journal Clubs!

Key Points

1. C. Difficile infections are a public health concern and put a heavy burden on the health care system
2. Patients experiencing recurrent infections often are subject to expensive and/or prolonged antibiotic regimens with an option for site specific fecal microbiota transplant (FMT) at the discretion of their gastroenterologist
3. SER-109 (VOWST) is an orally administered FMT that is intended to be standardized for commercial development that demonstrated a reduction in recurrent C. Diff rates and early re-engraftment of a healthy microbiome
4. What populations are best to analyze for efficacy and safety in this Phase III RCT? ---> Tune in to find out!

Erratum: Garrison mention's that patients on prednisone 20mg/day or more were excluded - this was an exclusion criteria for the Rebyota(R) trial and NOT the SER-109 VOWST trial.

As it related to immunosuppressed patients, the SER-109 (VOWST) trial excluded: 

1) Absolute neutrophil count of <500 cells/ml3

2) History of immunoglobulin (IgG) replacement therapy within the past 3 months

3) Concurrent intensive induction chemotherapy, radiotherapy, or biologic treatment for active malignancy (subjects on maintenance chemotherapy may only be enrolled after consultation with the study medical monitor)

References

1. [EPISODE TRIAL] Feuerstadt P, Louie TJ, Lashner B, et al.  SER-109, an oral microbiome therapy for recurrent Clostridioides difficile infection. NEJM 2022;386:220-229.
2. Johnson S, Lavergne V, Skinner AM, et al.  Clinical practice guideline by the Infectious Disease Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA): 2021 Focused update guidelines on management of Clostridioides difficile infection in adults. CID 2021:doi.10.1093/cid/ciab549.
3. Khanna S, Assi M, Lee C, et al. Efficacy and Safety of RBX2660 in PUNCH CD3, a Phase III, Randomized, Double-Blind, Placebo-Controlled Trial with a Bayesian Primary Analysis for the Prevention of Recurrent Clostridioides difficile Infection. Drugs. 2022;82(15):1527-1538.
   doi:10.1007/s40265-022-01797-x
4. [Equity check reference] Argamany JR, Delgado A, Reveles KR. Clostridium difficile infection health disparities by race among hospitalized adults in the United States, 2001 to 2010. BMC Infect Dis 2016;16(1): 454.

Contact Information

Podcast email: [email protected]

Host Information

Dr. Diana R. Langworthy, PharmD, BCPS

Clinical Associate Professor, University of Minnesota College of Pharmacy

Clinical Pharmacist - Inpatient Internal Medicine, M Health Fairview East Bank Hospital

Co-Host: Garrison Griest, P4 PharmD Student 2024, University of Minnesota

Expert Guest Information

Dr. Jennifer Ross, PharmD, BCIDP

Infectious Disease Clinical Pharmacist

East and West Bank Hospitals, M Health Fairview