1. Fecal Microbiota Transplantation Is Highly Effective in Real-World Practice: Initial Results From the FMT National Registry
- Author
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Adam C. Ehrlich, Daniel McDonald, Ashish Atreja, Loren Laine, James D. Lewis, Lea Ann Chen, Razvan Arsenescu, Monika Fischer, Joel Pekow, Rob Knight, Eugene F. Yen, Jonathan Goldstein, Ari Grinspan, Sahil Khanna, David T. Rubin, Dea Hunsicker, Paul Feuerstadt, Carl V. Crawford, Sonya Serra, Jennifer Vincent, R. K. Hsu, Lyn Tangen, Alison M. Kim, Yanina Nersesova, Jessica R. Allegretti, Mark Mattar, Gary D. Wu, Imad Absah, Lydia Fredell, Thomas A. Moore, David H. Kerman, Stacy A. Kahn, and Colleen R. Kelly
- Subjects
0301 basic medicine ,Abdominal pain ,Patient characteristics ,Inflammatory bowel disease ,law.invention ,Irritable Bowel Syndrome ,0302 clinical medicine ,Randomized controlled trial ,law ,Registries ,Prospective Studies ,Bacteriotherapy ,Irritable bowel syndrome ,Pain Research ,Gastroenterology ,Middle Aged ,Fecal Microbiota Transplantation ,Diarrhea ,Treatment Outcome ,030211 gastroenterology & hepatology ,Patient Safety ,medicine.symptom ,Adult ,Risk ,medicine.medical_specialty ,Adolescent ,Clinical Sciences ,Article ,Paediatrics and Reproductive Medicine ,Young Adult ,03 medical and health sciences ,Clinical Research ,Internal medicine ,medicine ,Humans ,Transplantation ,Gastroenterology & Hepatology ,Hepatology ,Clostridioides difficile ,business.industry ,Prevention ,Neurosciences ,Fecal bacteriotherapy ,Inflammatory Bowel Diseases ,medicine.disease ,United States ,Emerging Infectious Diseases ,030104 developmental biology ,Clostridium Infections ,Microbiome ,National registry ,Digestive Diseases ,business - Abstract
Background & aimsFecal 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.MethodsPatients 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.ResultsOf 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%).ConclusionsThis 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.
- Published
- 2020