The 6 Ds of Fecal Microbiota Transplantation

Jessica R. Allegretti, MD, MPH serves as the Associate Director of the Crohn’s and Colitis Center at Brigham and Women’s Hospital, Boston, Massachusetts, where she built and leads the Clinical Trials Program. She also founded the hospital’s Fecal Microbiota Transplantation Program and continues to serve as the program’s Director. Dr. Allegretti is a gastroenterologist and physician-scientist dedicated to discovering and developing innovative microbiome therapeutics and novel treatments for inflammatory bowel disease. She was awarded the IBD Rising Star Award by the New Chapter of the Crohn’s and Colitis Foundation her first year on staff. She serves on the Scientific Advisory Board for OpenBiome, the largest not-for-profit stool bank, and is the Clinical Development Lead for the Massachusetts-Host Microbiome Center. She has authored more than 100 abstracts and peer-reviewed publications in leading journals such as the New England Journal of Medicine, The Lancet, and Gastroenterology, and was recently appointed as an Associate Editor for the Inflammatory Bowel Diseases Journal. Dr. Allegretti has led multiple prospective microbiome therapeutic studies, including the first trials in primary sclerosing cholangitis and obesity. She has received funding from the National Institutes of Health, the American College of Gastroenterology, and the Crohn’s and Colitis Foundation. Dr. Allegretti has been featured on HBO, BBC, Netflix, the New York Times and numerous other media outlets. Dr. Allegretti was awarded her MD from the University of Miami. She completed her Internal Medicine training at Massachusetts General Hospital and her GI training at Brigham and Women’s Hospital. She went on to receive an MPH degree from the Harvard School of Public Health in Clinical Effectiveness, with a focus on clinical trials. In 2020, Dr. Allegretti received the Sherman Emerging Leader Prize for Excellence in Crohn’s and Colitis and Healio Gastroenterology’s Clinical Innovation Award for her work on microbial therapeutics. Zain Kassam, MD, MPH is Co-Founder and Chief Medical Officer at Finch Therapeutics, a clinical-stage company focused on developing novel microbiome therapeutics. Previously, he was a founding team member and Chief Medical Officer at OpenBiome, the world’s first public stool bank for fecal microbiota transplantation, where he helped pioneer the universal donor model and expand safe access to patients suffering from Clostridioides difficile infection. Dr. Kassam is a gastroenterologist, physician-scientist, and biotechnology entrepreneur dedicated to discovering and developing innovative microbiome therapeutics. He was named to the Top 40 Under 40 Healthcare Innovator List by MedTech and received the 2020 Public Health Innovator Award from the Harvard T.H. Chan School of Public Health. Dr. Kassam has served as a Scientific Advisory Board member for the American Gastroenterological Association Center for Gut Microbiome Research and Education, and as a Clinical Research Affiliate at the MIT Center for Microbiome Informatics and Therapeutics. He has authored more than 180 peer-reviewed publications, abstracts, and book chapters, including in leading journals such as the New England Journal of Medicine, Gastroenterology, and Gut. Dr. Kassam has been involved in more than 25 prospective microbiome therapeutic studies, including the first randomized trials in ulcerative colitis and hepatic encephalopathy. He has held funding from the Centers for Disease Control and Prevention, the Crohn’s and Colitis Foundation of America, and numerous private foundations. Dr. Kassam has been featured on PBS, CNN, BBC, The New Yorker, The Washington Post, and numerous other media outlets. Dr. Kassam received his MPH degree from Harvard University in Quantitative Methods and completed his post-doctoral training in microbiome engineering at MIT. He was awarded his MD from Western University in London, Canada, where he received the Young Alumni Award for his contributions to the microbiome field. Dr. Kassam completed his Internal Medicine and Gastroenterology training at McMaster University, Hamilton, Ontario, Canada, where he was both the Chief Medical and Chief Gastroenterology Resident.

Dedication Acknowledgments About the Editors Contributing Authors Chapter 1 Introduction Jessica R. Allegretti, MD, MPH and Zain Kassam, MD, MPH Chapter 2 Microbiome 101 Suzanne Devkota, PhD Chapter 3 The History of Fecal Microbiota Transplantation Joann Kwah, MD, FACG and Lawrence J. Brandt, MD, MACG, AGAF, FASGE Chapter 4 Decision: Which Patients With Clostridioides difficile Infection Are Appropriate for Fecal Microbiota Transplantation? Abbas Rupawala, MD and Colleen R. Kelly, MD Chapter 5 Decision: Considerations for Use of Fecal Microbiota Transplantation in Special Patient Populations Rohma Ghani, MBBS, MRCP and Benjamin H. Mullish, MB, BChir, MRCP, PhD Chapter 6 Donor: How Do You Select and Screen Candidate Donors for Fecal Microbiota Transplantation? Shrish Budree, MBChB, DCH, FCPaeds, Cert. Paeds Gastro. Chapter 7 Discussion: How Do You Discuss the Risks and Benefits of Fecal Microbiota Transplantation? Majdi Osman, MD, MPH and Pratik Panchal, MD, MPH Chapter 8 Delivery: How Do You Select the Most Appropriate Delivery Modality for Fecal Microbiota Transplantation? Paul Feuerstadt, MD, FACG, AGAF and Neil Stollman, MD, FACP, FACG, AGAF Chapter 9 Discharge: How Should You Follow and Care for Patients After Fecal Microbiota Transplantation? Lauren Tal Grinspan, MD, PhD and Ari M. Grinspan, MD Chapter 10 Discovery: Emerging Indications Jessica R. Allegretti, MD, MPH and Zain Kassam, MD, MPH 10.1 | Other Clostridioides difficile Indications10.1.1 | The Role of Fecal Microbiota Transplantation in the Treatment of Primary Clostridioides difficile InfectionAlexander Khoruts, MD10.1.2 | The Role of Fecal Microbiota Transplantation in the Treatment of Severe and Fulminant Clostridioides difficile InfectionMonika Fischer, MD, MSc and Sára Nemes, BA 10.2 | Gastrointestinal Indications: What Have We Learned?10.2.1 | The Role of Fecal Microbiota Transplantation in the Treatment of Inflammatory Bowel DiseaseLindsey Russell, MD, MSc and Paul Moayyedi, MD, PhD, MPH10.2.2 | The Role of Fecal Microbiota Transplantation in the Treatment of PouchitisJennifer D. Claytor, MD, MS and Najwa El-Nachef, MD10.2.3 | The Role of Fecal Microbiota Transplantation in the Treatment of Irritable Bowel SyndromeNeena Malik, MD, MSc and Olga C. Aroniadis, MD, MSc 10.3 | The Role of Fecal Microbiota Transplantation in the Treatment of Liver DiseasesChathur Acharya, MD and Jasmohan S. Bajaj, MD, MS 10.4 | The Role of Fecal Microbiota Transplantation in the Treatment of Autism Spectrum DisorderThomas J. Borody, MD, PhD, DSc and Anoja W. Gunaratne, BAMS (Hon), MSc, PhD 10.5 | The Role of Fecal Microbiota Transplantation in the Decolonization of Antibiotic-Resistant BacteriaChristopher Saddler, MD and Nasia Safdar, MD, PhD 10.6 | The Role of Fecal Microbiota Transplantation in the Treatment of Obesity, Metabolic Syndrome, and Nonalcoholic Fatty Liver DiseaseBenjamin H. Mullish, MB, BChir, MRCP, PhD Chapter 11 Frequently Asked Questions Jessica R. Allegretti, MD, MPH and Zain Kassam, MD, MPH Financial Disclosures Index