Gastroenterology. 2021 Jan;160(1):183-192.e3. doi: 10.1053/j.gastro.2020.09.038. Epub 2020 Oct 1.

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, Rhode Island. Electronic address: colleen_r_kelly@brown.edu.

²Division of Gastroenterology, NorthShore University HealthSystem, Evanston, Illinois.

³Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York.

⁴Division of Gastroenterology, Hepatology and Nutrition, Boston Children's Hospital, Boston, Massachusetts.

⁵Division of Gastroenterology and Hepatology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.

⁶Infectious Disease Consultants, Wichita, Kansas.

⁷Section of Gastroenterology, Hepatology, and Nutrition, University of Chicago Medicine, Chicago, Illinois.

⁸American Gastroenterological Association, Bethesda, Maryland.

⁹OpenBiome, Cambridge, Massachusetts.

¹⁰Department of Pediatrics, University of California San Diego, La Jolla, California.

¹¹Department of Pediatrics, University of California San Diego, La Jolla, California; Center for Microbiome Innovation, University of California San Diego, La Jolla, California; Department of Computer Science and Engineering, University of California San Diego, La Jolla, California; Department of Bioengineering, University of California San Diego, La Jolla, California.

¹²Division of Gastroenterology, Brigham and Women's Hospital, Boston, Massachusetts.

¹³Division of Pediatric Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.

¹⁴Sutter Health, Sutter Institute for Medical Research and Division of Gastroenterology, School of Medicine, University of California, Davis, California.

¹⁵Division of Gastroenterology, Baylor Scott and White Research Institute, Temple, Texas.

¹⁶Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.

¹⁷Carle Foundation Hospital, Urbana, Illinois.

¹⁸Division of Gastroenterology, Weill Cornell Medicine, New York, New York.

¹⁹Division of Gastroenterology, MedStar Georgetown University Hospital, Washington, District of Columbia.

²⁰Division of Gastroenterology and Hepatology, New York University Grossman School of Medicine, New York, New York.

²¹Division of Gastroenterology, Indiana University, Indianapolis, Indiana.

²²Atlantic Inflammatory Bowel Disease Center of Excellence, Atlantic Digestive Health Institute, Morristown, New Jersey.

²³Gastroenterology Center of Connecticut, Hamden, Connecticut.

²⁴Gastroenterology Group of Rochester, Rochester, New York.

²⁵Division of Gastroenterology, University of Miami Miller School of Medicine, Miami, Florida.

²⁶Section of Gastroenterology, Lewis Katz School of Medicine at Temple University, Philadelphia, Pennsylvania.

²⁷Yale School of Medicine, New Haven, Connecticut; Veterans Affairs Connecticut Healthcare System, West Haven, Connecticut.

Abstract

Background & aims: Fecal microbiota transplantation (FMT) is used commonly for treatment of Clostridioides difficile infections (CDIs), 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 were 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 had completed short-term follow-up at 1 month and 123 had follow-up to 6 months; 171 (66%) were female. All FMTs were done for CDI and 249 (96%) used an unknown donor (eg, stool bank). One-month cure occurred in 200 patients (90%); of these, 197 (98%) received only 1 FMT. Among 112 patients with initial cure who were followed to 6 months, 4 (4%) had CDI recurrence. Severe symptoms reported within 1-month of FMT included diarrhea (n = 5 [2%]) and abdominal pain (n = 4 [2%]); 3 patients (1%) had hospitalizations possibly related to FMT. At 6 months, new diagnoses of irritable bowel syndrome were made in 2 patients (1%) and inflammatory bowel disease in 2 patients (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.