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Breaking the Cycle: The Role of Microbiota-Based Biotherapies in the Reduction of Recurrent Clostridioides difficile

Symposium Highlights

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Breaking the Cycle: The Role of Microbiota-Based Biotherapies in the Reduction of Recurrent Clostridioides difficile
Format
Symposium Highlights
Time to Complete
1.25 hr(s).
Release Date
November 30, 2022
Expires On
November 30, 2023

Drs. Paul Feuerstadt, Sahil Khanna, Teena Chopra and Caterina Oneto convened at annual gastroenterology and infectious disease congresses to discuss clinical scenarios and best practices to manage recurrent Clostridioides difficile (C. difficile) infections; this activity chronicles their discussions. Tune in for updates on risk factors and prevention strategies for recurrent infection, as well as up-and-coming treatment options such as cutting-edge microbiota restoration therapies as discussed through a series of real-world patient cases. 

This educational activity is designed for gastroenterologists, ID physicians, hospitalists, critical care physicians, pharmacists, and other healthcare providers who treat patients at risk for C. difficile infection.

Clostridioides difficile (C. difficile) is a gram-positive bacterium that infects the colon and causes diarrhea, abdominal bloating, and occasionally colitis. C. difficile infection is associated with significant morbidity and mortality, increased healthcare costs, and hospital readmission rates. 

The epidemiology and incidence of C. difficile infections have changed over the past decade, and recurrence continues to pose significant burdens on patients, clinicians, and the healthcare system. Recurrent C. difficile infections can occur in up to 35% of patients who previously had C. difficile infection, usually as a result of the disruption of the intestinal microbiota. Recurrent C. difficile infections are associated with longer hospital stays and higher healthcare costs compared with an initial episode. Therefore, clinicians must be familiar with the risk factors for recurrence, as well as treatment options to prevent multiple recurrences to break the cycle.  Microbiota restoration therapies including fecal microbiota transplant (FMT) has shown efficacy in treatment of recurrent C. difficile infections by correcting intestinal dysbiosis. However, FMT itself poses some difficulties associated with safety, and novel live biotherapeutic products (LBPs) are under investigation in phase 2 and 3 trials to overcome these limitations. As such, clinicians must be familiar with the assessment of risk factors, updated clinical guidelines, and available treatment options to reduce recurrences and improve patient outcomes.

Upon completion of this activity, participants will be able to:
• Describe the integral role of the intestinal microbiota in C. difficile infection and the importance of microbiota restoration for prevention of recurrence
• Distinguish the benefits and limitations of fecal microbiota transplantation for the treatment and prevention of recurrent C. difficile in patients failing appropriate antibiotic therapy
• Analyze clinical trial data on emerging microbiota restoration therapies 
• Discuss the emerging potential of microbiota restoration therapies for patients with recurrent C. difficile infections

Agenda/Topics 

Case #1: Andrew / Diagnosis and Treatment of an Initial Episode of C. difficile Infection
Case #2: Stephanie / Recurrent C. difficile Infection in a Patient With No Risk Factors
Case #2: Jason / Recurrent C. difficile Infection in a Patient With Multiple Risk Factors
Epidemiology of C. difficile 
Pathogenesis of C. difficile Infection 
Diagnosis of C. difficile Infection 
Treatment of C. difficile Infection 
Introduction to Prevention and Treatment of Recurrent C. difficile Infection 
Bezlotoxumab for Prevention of Recurrent C. difficile Infection 
FMT for Treatment of Recurrent C. difficile Infection 
LBPs for Treatment of Recurrent C. difficile Infection

Sponsored by the Academy for Continued Healthcare Learning (ACHL). 

Supported by an educational grant from Ferring Pharmaceuticals, Inc.  

1. Active Internet connection (DSL or Cable). Dial-up connection will have constant buffering problem.
2. Compatible with Windows PC and MAC (256 MB of RAM or higher)
3. Activity is best viewed on Internet Explorer 9.0 or higher, Safari 5.0 or higher and Firefox 29.0 or higher
4. Adobe Flash Player 12.0 (or higher). Click here to download Adobe Flash Player for free.
5. Adobe Reader to print certificate. Click here to download Adobe Reader for free.
6. Allow ActiveX controls to run on your computer: If the yellow strip appears on the top of your web browser while running the Webcast, right click on it and select Allow blocked contents to run.
7. Turn the Pop-up blocker off: On the Tools menu, point to Pop-up Blocker, and then click Turn Off Pop-up Blocker

On April 26, 2023, fecal microbiota spores, live-brpk (SER-109) received FDA approval to prevent the recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older following antibacterial treatment for recurrent CDI.

On November 30, 2022, fecal microbiota, live-jslm (RBX2660) received FDA approval for the prevention of recurrence of Clostridioides difficile infection in individuals 18 years of age and older, following antibiotic treatment for recurrent CDI.

Teena Chopra, MD, MPH
Professor of Medicine, Division of Infectious Diseases
Corporate Medical Director, Infection Prevention, Epidemiology and Antibiotic Stewardship
Detroit Medical Center
Wayne State University
Director, Infection Prevention
Epidemiology and Antibiotic Stewardship
Vibra Hospital
Detroit, MI

Paul Feuerstadt MD, FACG, AGAF 
Assistant Clinical Professor of Medicine
Yale University School of Medicine
Gastroenterology Center of Connecticut
Hamden, CT 

Sahil Khanna, MBBS, MS, FACG 
Professor of Medicine
Gastroenterology and Hepatology
Mayo Clinic
Rochester, MN 

Caterina Oneto, MD 
NYU Grossman School of Medicine 
New York University Langone  
New York, NY

The Academy for Continued Healthcare Learning (ACHL) requires that the faculty participating in an accredited continuing education activity disclose all affiliations or other financial relationships (1) with the manufacturers of any commercial product(s) and/or provider(s) of commercial services discussed in an educational presentation and (2) with any ineligible companies. All relevant financial relationships have been mitigated prior to this activity. 

The following financial relationships have been provided:
Teena Chopra, MD, MPH  
Consulting Agreements: Ferring Pharmaceuticals, Merck, Pfizer, Shionogi
Speakers' Bureau: Abbvie, Ferring Pharmaceuticals, Pfizer, Shionogi 

Paul Feuerstadt MD, FACG, AGAF 
Consulting Agreements: Ferring Pharmaceuticals, Roche Diagnostics, SERES Therapeutics, Takeda Pharmaceuticals
Speakers' Bureau: Merck and Co.

Sahil Khanna, MBBS, MS, FACG 
Sources of Funding for Grant/Research: Robiotix/Ferring, Seres Therapeutics, Finch Therapeutics, Vedanta, Pfizer
Consulting Agreements: Immuron, Niche, ProBio Tech, Jetson, Shire/Takeda
Stockholder: Jetson (relationship ended April 2022) 

Caterina Oneto, MD 
Speakers’ Bureau: Abbvie, BMS, Pfizer, Salix 

Discussion of Off-Label, Investigational, or Experimental Drug/Device Use: Fecal microbiota transplant (FMT) and microbiota-based live therapies (SER-109, CP101, VE303) for treatment of recurrent C. difficile infections

ACHL staff members and others involved with the planning, development, and review of the content for this activity have no relevant affiliations or financial relationships to disclose. 

The content for this activity was developed independently of the ineligible company. All materials are included with permission. The opinions expressed are those of the faculty and are not to be construed as those of the publisher or grantor.

This educational activity was planned and produced in accordance with the ACCME Standards for Integrity and Independence in Accredited Continuing Education. Recommendations involving clinical medicine in a continuing medical education (CME/CE) activity must be based on evidence that is accepted within the profession of medicine as adequate justification for their indications and contraindications in the care of patients. All scientific research referred to, reported, or used in CME/CE in support or justification of a patient care recommendation must conform to the generally accepted standards of experimental design, data collection, and analysis.

This CME/CE activity might describe the off-label, investigational, or experimental use of medications that may exceed their FDA-approved labeling. Physicians should consult the current manufacturers’ prescribing information for these products. ACHL requires its speakers to disclose that a product is not labeled for the use under discussion.

This activity will take approximately 75 minutes to complete. To receive credit, participants are required to complete the pretest, view the online activity, and complete the posttest and evaluation. To receive credit, 80% must be achieved on the posttest. A certificate will be immediately available. There is no fee to participate in the activity or for the generation of the certificate.

For questions, contact Karen Catino at kcatino@achlcme.org  

CPE credit will be submitted to CPE Monitor®  on the first business day of each month.

The Academy for Continued Healthcare Learning is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

The Academy for Continued Healthcare Learning designates this enduring material for a maximum of 1.25 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

The Academy for Continued Healthcare Learning is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. 

This activity has been approved for 1.25 contact hours.

ACPE Universal Activity Number: 0396-0000-22-042-H01-P
Activity Type(s): Application

Release Date: November 30, 2022
Expiration Date: November 30, 2023 

Karen Catino
kcatino@achlcme.org
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