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

doi:10.1053/j.gastro.2020.09.038

Observational Study

. 2021 Jan;160(1):183-192.e3.

doi: 10.1053/j.gastro.2020.09.038. Epub 2020 Oct 1.

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

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

Affiliations

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.

PMID: 33011173
PMCID: PMC8034505
DOI: 10.1053/j.gastro.2020.09.038

Observational Study

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

Colleen R Kelly et al. Gastroenterology. 2021 Jan.

. 2021 Jan;160(1):183-192.e3.

doi: 10.1053/j.gastro.2020.09.038. Epub 2020 Oct 1.

Authors

Affiliations

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.

PMID: 33011173
PMCID: PMC8034505
DOI: 10.1053/j.gastro.2020.09.038

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.

Keywords: Bacteriotherapy; Microbiome; Risk.

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Conflict of interest statement

Conflicts of interest

These authors disclose the following: Colleen R. Kelly: research support from Finch Therapeutics for a clinical trial; unpaid clinical advisor to OpenBiome. Ari M. Grinspan: lecture fees from Merck. Stacy A. Kahn: unpaid research collaboration with OpenBiome; pilot award (principal investigator) from Cures Within Reach; Mooney Fund Research Award (principal investigator). James D. Lewis: consulting for Merck and Pfizer, outside of submitted work. David T. Rubin: no disclosures relevant to the submitted work, but has received research support from Takeda and serves as a consultant for Abbvie, Abgenomics, Allergan, Inc, Arena Pharmaceuticals, Biomica, Bristol-Myers Squibb, Dizal Pharmaceuticals, Ferring Pharmaceuticals, Inc, Genentech/ Roche, Janssen Pharmaceuticals, Lilly, Mahana Therapeutics, Medtronic, Merck & Co., Inc, Napo Pharmaceuticals, Pfizer, Prometheus Laboratories, Shire, Takeda, and Target PharmaSolutions, Inc. Jessica R. Allegretti: consults for Finch Therapeutics, Servatus, and Artugen and is an unpaid advisor to Openbiome. Jessica R. Allegretti has research support from Merck. Sahil Khanna: research grants from Rebiotix, Inc (A Ferring Company), consulting fees from Shire Plc, Premier Inc, Facile therapeutics, ProbioTech Inc, outside of the submitted work. Carl V. Crawford: research support from Finch Therapeutics, Summit, Ferring, and Artugen for clinical trials. Speaker for Merck and Romark. Monika Fischer: on data and safety monitoring board for Rebiotix; unpaid clinical advisor to OpenBiome. Paul Feuerstadt: consulting fees for Merck and Co., Rebiotix (A Ferring Company), Roche Diagnostics and Premier Inc David Kerman: Consultant to Abbvie, Cleveland Clinic, Advisory Board Rebiotix. Jonathan Goldstein: research support from Rebiotix. Gary D. Wu: research support from Intercept Pharmaceuticals, Seres Therapeutics, and Takeda Pharmaceuticals; scientific consultant for the Hitachi Corporation; and a scientific advisory board member for Biocodex and Danone. The remaining authors disclose no conflicts.

Figures

**Figure 1.**
Distribution of registry sites by total number of subjects enrolled.

See this image and copyright information in PMC

Comment in

Fecal Microbiota Transplantation "Donor Effects" Are Not Clinically Relevant for Clostridioides difficile Infection.
Olesen SW. Olesen SW. Gastroenterology. 2021 Jun;160(7):2635-2636. doi: 10.1053/j.gastro.2020.12.057. Epub 2020 Dec 30. Gastroenterology. 2021. PMID: 33387515 No abstract available.
Reply.
Kelly CR, Wu GD, Laine LA. Kelly CR, et al. Gastroenterology. 2021 Jun;160(7):2636. doi: 10.1053/j.gastro.2021.02.045. Epub 2021 Feb 25. Gastroenterology. 2021. PMID: 33639155 No abstract available.

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References

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1. Lessa FC, Mu Y, Bamberg WM, et al. Burden of Clostridium difficile infection in the United States. N Engl J Med 2015;372:825–834. - PMC - PubMed
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[1] Ma GK, Brensinger CM, Wu Q, et al. Increasing incidence of multiply recurrent clostridium difficile infection in the United States: a cohort study. Ann Intern Med 2017; 167:152–158. - PubMed

[2] Ma GK, Brensinger CM, Wu Q, et al. Increasing incidence of multiply recurrent clostridium difficile infection in the United States: a cohort study. Ann Intern Med 2017; 167:152–158. - PubMed

[3] Lessa FC, Mu Y, Bamberg WM, et al. Burden of Clostridium difficile infection in the United States. N Engl J Med 2015;372:825–834. - PMC - PubMed

[4] Lessa FC, Mu Y, Bamberg WM, et al. Burden of Clostridium difficile infection in the United States. N Engl J Med 2015;372:825–834. - PMC - PubMed

[5] McFarland LV, Elmer GW, Surawicz CM. Breaking the cycle: treatment strategies for 163 cases of recurrent Clostridium difficile disease. Am J Gastroenterol 2002; 97:1769–1775. - PubMed

[6] McFarland LV, Elmer GW, Surawicz CM. Breaking the cycle: treatment strategies for 163 cases of recurrent Clostridium difficile disease. Am J Gastroenterol 2002; 97:1769–1775. - PubMed

[7] Moayyedi P, Yuan Y, Baharith H, et al. Faecal microbiota transplantation for Clostridium difficile-associated diarrhoea: a systematic review of randomised controlled trials. Med J Aust 2017;207:166–172. - PubMed

[8] Moayyedi P, Yuan Y, Baharith H, et al. Faecal microbiota transplantation for Clostridium difficile-associated diarrhoea: a systematic review of randomised controlled trials. Med J Aust 2017;207:166–172. - PubMed

[9] Fischer M, Sipe B, Cheng YW, et al. Fecal microbiota transplant in severe and severe-complicated Clostridium difficile: a promising treatment approach. Gut Microbes 2017;8:289–302. - PMC - PubMed

[10] Fischer M, Sipe B, Cheng YW, et al. Fecal microbiota transplant in severe and severe-complicated Clostridium difficile: a promising treatment approach. Gut Microbes 2017;8:289–302. - PMC - PubMed

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

Affiliations

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

Authors

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Abstract

Conflict of interest statement

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