Fecal Microbiota Transplantation Is Highly Effective in Real-World Practice: Initial Results From the FMT National Registry

Colleen R. Kelly, Eugene F. Yen, Ari M. Grinspan, Stacy A. Kahn, Ashish Atreja, James D. Lewis, Thomas A. Moore, David T. Rubin, Alison M. Kim, Sonya Serra, Yanina Nersesova, Lydia Fredell, Dea Hunsicker, Daniel McDonald, Rob Knight, Jessica R. Allegretti, Joel Pekow, Imad Absah, Ronald Hsu, Jennifer VincentSahil Khanna, Lyn Tangen, Carl V. Crawford, Mark C. Mattar, Lea Ann Chen, Monika Fischer, Razvan I. Arsenescu, Paul Feuerstadt, Jonathan Goldstein, David Kerman, Adam C. Ehrlich, Gary D. Wu, Loren Laine

Research output: Contribution to journalArticlepeer-review

16 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)183-192.e3
JournalGastroenterology
Volume160
Issue number1
DOIs
StatePublished - Jan 2021
Externally publishedYes

All Science Journal Classification (ASJC) codes

  • Hepatology
  • Gastroenterology

Keywords

  • Bacteriotherapy
  • Microbiome
  • Risk

Fingerprint

Dive into the research topics of 'Fecal Microbiota Transplantation Is Highly Effective in Real-World Practice: Initial Results From the FMT National Registry'. Together they form a unique fingerprint.

Cite this