Fecal Microbiota Transplant is Highly Effective in Real-World Practice: Initial Results from the FMT National Registry

Gastroenterology. 2020 Sep 30;S0016-5085(20)35221-5. doi: 10.1053/j.gastro.2020.09.038.Online ahead of print.

Colleen R Kelly 1, Eugene F Yen 2, Ari M Grinspan 3, Stacy A Kahn 4, Ashish Atreja 3, James D Lewis 5, Thomas A Moore 6, David T Rubin 7, Alison M Kim 8, Sonya Serra 8, Yanina Nersesova 8, Lydia Fredell 8, Dea Hunsicker 9, Daniel McDonald 10, Rob Knight 11, Jessica R Allegretti 12, Joel Pekow 7, Imad Absah 13, Ronald Hsu 14, Jennifer Vincent 15, Sahil Khanna 16, Lyn Tangen 17, Carl V Crawford 18, Mark C Mattar 19, Lea Ann Chen 20, Monika Fischer 21, Razvan I Arsenescu 22, Paul Feuerstadt 23, Jonathan Goldstein 24, David Kerman 25, Adam C Ehrlich 26, Gary D Wu 5, Loren Laine 27


Author information

  • 1Department of Medicine, Warren Alpert Medical School of Brown University, Providence, RI. Electronic address: colleen_r_kelly@brown.edu.
  • 2Division of Gastroenterology, NorthShore University HealthSystem, Evanston, IL.
  • 3Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, NY.
  • 4Division of Gastroenterology, Hepatology and Nutrition, Boston Children's Hospital, Boston, MA.
  • 5Division of Gastroenterology and Hepatology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.
  • 6Infectious Disease Consultants, KS.
  • 7Section of Gastroenterology, Hepatology, and Nutrition, University of Chicago Medicine, Chicago, IL.
  • 8American Gastroenterological Association, Bethesda, MD.
  • 9OpenBiome, Cambridge, MA.
  • 10Department of Pediatrics, University of California San Diego, La Jolla, CA.
  • 11Department of Pediatrics, University of California San Diego, La Jolla, CA; Center for Microbiome Innovation, University of California San Diego, La Jolla, CA; Department of Computer Science and Engineering, University of California San Diego, La Jolla, CA; Department of Bioengineering, University of California San Diego, La Jolla, CA.
  • 12Division of Gastroenterology, Brigham and Women's Hospital, Boston, MA.
  • 13Division of Pediatric Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN.
  • 14Sutter Health, Sutter Institute for Medical Research and Division of Gastroenterology, School of Medicine, University of California, Davis, CA.
  • 15Division of Gastroenterology, Baylor Scott and White Research Institute, Temple, TX.
  • 16Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN.
  • 17Carle Foundation Hospital, Urbana, IL.
  • 18Division of Gastroenterology, Weill Cornell Medicine, New York, NY.
  • 19Division of Gastroenterology, MedStar Georgetown University Hospital, Washington, DC.
  • 20Division of Gastroenterology and Hepatology, New York University Grossman School of Medicine, New York, NY.
  • 21Division of Gastroenterology, Indiana University, Indianapolis, IN.
  • 22Atlantic Inflammatory Bowel Disease Center of Excellence, Atlantic Digestive Health Institute, Morristown, NJ.
  • 23Gastroenterology Center of Connecticut, Hamden, CT.
  • 24Gastroenterology Group of Rochester, Rochester, NY.
  • 25Division of Gastroenterology University of Miami Miller School of Medicine, Miami, FL.
  • 26Section of Gastroenterology, Lewis Katz School of Medicine at Temple University, Philadelphia, PA.
  • 27Yale School of Medicine, New Haven, CT and VA Connecticut Healthcare System, West Haven, CT.


Introduction: Fecal microbiota transplantation (FMT) is commonly used for treatment of C. difficile infections (CDI), although prospective safety data are limited and real-world FMT practice and outcomes are not well described. The FMT National Registry was designed to assess FMT methods and both safety and effectiveness outcomes from North American FMT providers.

Methods: Patients undergoing FMT in clinical practices across North America are eligible. Participating investigators enter de-identified data into an online platform including FMT protocol, baseline patient characteristics, CDI cure and recurrence, and short and long-term safety outcomes.

Results: Of the first 259 participants enrolled at 20 sites, 222 have completed short-term follow-up at 1 month, and 123 have follow-up to 6 months; 171 (66%) are female. All FMTs were done for CDI, and 249 (96%) used an unknown donor (e.g., stool bank). One-month cure occurred in 200 (90%); of these, 197 (98%) received only a single FMT. Among 112 with initial cure who were followed to 6 months, 4 (4%) had CDI recurrence. Severe symptoms reported within 1-month of FMT included diarrhea (5 (2%)) and abdominal pain (4 (2%)); 3 (1%) had hospitalizations possibly related to FMT. At 6 months, new diagnoses of irritable bowel syndrome were made in 2 (1%) and inflammatory bowel disease in 2 (1%).

Conclusions: This prospective real-world study demonstrated high effectiveness of FMT for CDI with a good safety profile. Assessment of new conditions at long-term follow-up is planned as this registry grows and will be important for determining the full safety profile of FMT.

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