Breaking the Cycle: The Role of Microbiota-Based Biotherapies in the Reduction of Recurrent Clostridioides difficile
November 30, 2022
November 30, 2023
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Sponsored by The Academy for Continued Healthcare Learning (ACHL).
This activity is supported by an educational grant from Ferring Pharmaceuticals, Inc.
- Physicians — maximum of 1.25 AMA PRA Category 1 Credit(s)™
- Pharmacists — 1.25 contact hours
All other healthcare professionals completing this course will be issued a statement of participation.
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.
Approval Update: 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.
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 should 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
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
Paul Feuerstadt MD, FACG, AGAF
Assistant Clinical Professor of Medicine
Yale University School of Medicine
Gastroenterology Center of Connecticut
Sahil Khanna, MBBS, MS, FACG
Professor of Medicine
Gastroenterology and Hepatology
Caterina Oneto, MD
Clinical Assistant Professor, Gastroenterology
NYU Grossman School of Medicine
New York University Langone
New York, NY
Physician Continuing Education
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(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Continuing Pharmacy Education Statement
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
Disclosures of Conflicts of Interest
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
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.
Off Label Statement
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.
Instructions for Participation and Credit
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 firstname.lastname@example.org.
CPE credit will be submitted to CPE Monitor® on the first business day of each month.
- 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
- Guidelines for Management of C. difficile Infection
- Introduction to Prevention and Treatment of Recurrent C. difficile Infection
- Updates from the National Meeting, 2002
- FMT in the Guidelines
- Bezlotoxumab for Prevention of Recurrent C. difficile Infection
- FMT for Treatment of Recurrent C. difficile Infection
- LBPs for Treatment of Recurrent C. difficile Infection
Course Viewing Requirements
Internet Explorer 8.0+ for Windows 2003, Vista, XP, Windows 7, Windows 8.1 and above
Google Chrome 28.0+ for Windows, Mac OS, or Linux
Mozilla Firefox 23.0+ for Windows, Mac OS, or Linux
Safari 6.0+ for Mac OSX 10.7 and above
Supported Phones & Tablets:
Android 4.0.3 and above
iPhone/iPad with iOS 6.1 or above.
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.
For CME questions, please email@example.com.
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