ABSTRACTS FOR ORAL PRESENTATION
Maximizing Clinical Trial Design in Evaluating Safety and Efficacy of Microbiota-Based Therapies for Recurrent Clostridium difficile Infection: The Added Insight of Microbiome Profiling and the Microbiome Health Index in Two Phase 2 Controlled Trials of RBX2660
Presenter: Sarah Mische, PhD
Sarah Mische PhD1, Robert Orenstein DO2, Erik Dubberke3, Sahil Khanna MBBS4, Gail Hecht MD5 , Herbert Dupont MD6, Christine H. Lee7, Dale N. Gerding, MD8, Ken Blount PhD1
1Rebiotix, Inc. Roseville, MN; 2Division of Infectious Diseases, Mayo Clinic in Arizona, Phoenix, AZ, USA; 3Department of Internal Medicine, Washington University of St. Louis, St. Louis, MO; 4Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA; 5Division of Gastroenterology and Nutrition, Loyola University Medical Center, Chicago, IL, USA; 6University of Texas Health Science Center, Houston, TX, USA; 7Hamilton Regional Laboratory Medicine Program, Department of Pathology and Molecular Medicine, McMaster University, Hamilton, ON, Canada, Vancouver Island Health Authority, Victoria, Department of Pathology and Laboratory Medicine, University of British Columbia, BC, Canada; 8Loyola University Stritch School of Medicine, Maywood, IL, Edward Hines Jr. VA Hospital, Hines, IL, USA
“Evaluation of Clostridium difficile burden using high-resolution gut microbiome profiling”
Presenter: James Robert White, PhD
Author: James Robert White, PhD
The human intestinal tract contains thousands of unique microbial species that in aggregate constitute the gut microbiome. To study these microorganisms at the community level, scientists employ DNA sequencing techniques that allow for sampling of the total bacterial diversity within a stool specimen, including known pathogens such as Clostridium difficile. Here, we will provide an overview of advanced microbiome profiling strategies and apply these techniques to characterization of the burden of C. difficile in critical patient populations. Finally, we will describe gut bacterial species that show consistent negative correlations with C. difficile, suggesting the potential for a protective effect against C. difficile infection.
Resphera Biosciences is developing innovative computational and statistical approaches to microbiome sequence analysis that deliver clinically relevant results, enabling doctors and scientists to better identify potential pathogens and characterize dysbiosis in complex microbial environments. Resphera Biosciences is located in Baltimore, MD USA
“Perception of Quality of Life among People Experiencing or Having Experienced a Clostridium difficile Infection in the United States: Qualitative Review of Respondents’ Verbatim.”
Presenter: Caterina Oneto, MD
- Lise Lurienne, Da Volterra, Paris, France
- Pierre Alain Bandinelli, Da Volterra, Paris, France
- Thibaut Galvain, Da Volterra, Paris, France
- Charles-Alexis Coursel, Da Volterra, Paris, France
- Caterina Oneto, Concorde Medical Group, New York, USA
- Paul Feuerstadt, FACG, Gastroenterology Center of Connecticut, Connecticut, USA
INTRODUCTION: Although the incidence, severity and mortality of Clostridium difficile infections (CDI) have been increasing, patients’ quality of life changes resulting from CDI have not been studied thoroughly. This study aimed at exploring the physical, psychological, social and financial consequences of CDI for patients during and after the disease.
“Treatment of recurrent Clostridium difficile infection with SER-109 increases the concentration of secondary bile acids in a dose dependent manner.”
Presenter: Edward O’Brien
Authors: Matthew Henn1*, Christopher Ford1*, Edward O’Brien1*, Jennifer Wortman1, Liyang Diao1, Christopher Desjardins1, Amelia Tomlinson1, Madhu Nandakumar1, Kevin Litcofsky1, Mark Wilcox2, 3, Anthony Buckley2, Patricia Bernardo1, Barbara McGovern1, John Aunins1, David Cook1, and Michele Trucksis1
1Seres Therapeutics, Cambridge, MA, United States
Background: C. difficile recurs when dormant spores germinate in the dysbiotic gut, facilitated by an increase of 1° vs 2° bile acids. SER-109, an ecology of bacterial spores purified from stool of healthy donors, is an investigational first-in-class microbiome therapeutic intended to facilitate microbiome restoration and reduce risk of recurrent C. difficile (rCDI). Rapid engraftment of spore-forming species is associated with 1) higher doses of SER-109 in our dose-ranging Phase 1b study (Ph1b) and 2) reduced rCDI in our Phase 2 trial (Ph2). We explored whether higher doses of SER-109 were associated with a functional increase in 2° bile acids.