Colleen R Kelly1, Eugene F Yen2, Ari M Grinspan3, Stacy A Kahn4, Ashish Atreja3, James D Lewis5, Thomas A Moore6, David T Rubin7, Alison M Kim8, Sonya Serra8, Yanina Nersesova8, Lydia Fredell8, Dea Hunsicker9, Daniel McDonald10, Rob Knight11, Jessica R Allegretti12, Joel Pekow7, Imad Absah13, Ronald Hsu14, Jennifer Vincent15, Sahil Khanna16, Lyn Tangen17, Carl V Crawford18, Mark C Mattar19, Lea Ann Chen20, Monika Fischer21, Razvan I Arsenescu22, Paul Feuerstadt23, Jonathan Goldstein24, David Kerman25, Adam C Ehrlich26, Gary D Wu5, Loren Laine27. 1. Department of Medicine, Warren Alpert Medical School of Brown University, Providence, Rhode Island. Electronic address: colleen_r_kelly@brown.edu. 2. Division of Gastroenterology, NorthShore University HealthSystem, Evanston, Illinois. 3. Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York. 4. Division of Gastroenterology, Hepatology and Nutrition, Boston Children's Hospital, Boston, Massachusetts. 5. Division of Gastroenterology and Hepatology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania. 6. Infectious Disease Consultants, Wichita, Kansas. 7. Section of Gastroenterology, Hepatology, and Nutrition, University of Chicago Medicine, Chicago, Illinois. 8. American Gastroenterological Association, Bethesda, Maryland. 9. OpenBiome, Cambridge, Massachusetts. 10. Department of Pediatrics, University of California San Diego, La Jolla, California. 11. Department 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. 12. Division of Gastroenterology, Brigham and Women's Hospital, Boston, Massachusetts. 13. Division of Pediatric Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota. 14. Sutter Health, Sutter Institute for Medical Research and Division of Gastroenterology, School of Medicine, University of California, Davis, California. 15. Division of Gastroenterology, Baylor Scott and White Research Institute, Temple, Texas. 16. Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota. 17. Carle Foundation Hospital, Urbana, Illinois. 18. Division of Gastroenterology, Weill Cornell Medicine, New York, New York. 19. Division of Gastroenterology, MedStar Georgetown University Hospital, Washington, District of Columbia. 20. Division of Gastroenterology and Hepatology, New York University Grossman School of Medicine, New York, New York. 21. Division of Gastroenterology, Indiana University, Indianapolis, Indiana. 22. Atlantic Inflammatory Bowel Disease Center of Excellence, Atlantic Digestive Health Institute, Morristown, New Jersey. 23. Gastroenterology Center of Connecticut, Hamden, Connecticut. 24. Gastroenterology Group of Rochester, Rochester, New York. 25. Division of Gastroenterology, University of Miami Miller School of Medicine, Miami, Florida. 26. Section of Gastroenterology, Lewis Katz School of Medicine at Temple University, Philadelphia, Pennsylvania. 27. Yale 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.
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.
Authors: G Cammarota; L Masucci; G Ianiro; S Bibbò; G Dinoi; G Costamagna; M Sanguinetti; A Gasbarrini Journal: Aliment Pharmacol Ther Date: 2015-03-01 Impact factor: 8.171
Authors: Colleen R Kelly; Chioma Ihunnah; Monika Fischer; Alexander Khoruts; Christina Surawicz; Anita Afzali; Olga Aroniadis; Amy Barto; Thomas Borody; Andrea Giovanelli; Shelley Gordon; Michael Gluck; Elizabeth L Hohmann; Dina Kao; John Y Kao; Daniel P McQuillen; Mark Mellow; Kevin M Rank; Krishna Rao; Arnab Ray; Margot A Schwartz; Namita Singh; Neil Stollman; David L Suskind; Stephen M Vindigni; Ilan Youngster; Lawrence Brandt Journal: Am J Gastroenterol Date: 2014-06-03 Impact factor: 10.864
Authors: L V McFarland; C M Surawicz; M Rubin; R Fekety; G W Elmer; R N Greenberg Journal: Infect Control Hosp Epidemiol Date: 1999-01 Impact factor: 3.254
Authors: Brynn A Hollingsworth; David R Cassatt; Andrea L DiCarlo; Carmen I Rios; Merriline M Satyamitra; Thomas A Winters; Lanyn P Taliaferro Journal: Front Pharmacol Date: 2021-05-18 Impact factor: 5.810
Authors: Daniel Popa; Bogdan Neamtu; Manuela Mihalache; Adrian Boicean; Adela Banciu; Daniel Dumitru Banciu; Doru Florian Cornel Moga; Victoria Birlutiu Journal: J Clin Med Date: 2021-12-13 Impact factor: 4.241