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 language | English |
---|---|
Pages (from-to) | 183-192.e3 |
Journal | Gastroenterology |
Volume | 160 |
Issue number | 1 |
DOIs | |
State | Published - Jan 2021 |
Keywords
- Bacteriotherapy
- Microbiome
- Risk
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Fecal Microbiota Transplantation Is Highly Effective in Real-World Practice : Initial Results From the FMT National Registry. / Kelly, Colleen R.; Yen, Eugene F.; Grinspan, Ari M. et al.
In: Gastroenterology, Vol. 160, No. 1, 01.2021, p. 183-192.e3.Research output: Contribution to journal › Article › peer-review
TY - JOUR
T1 - Fecal Microbiota Transplantation Is Highly Effective in Real-World Practice
T2 - Initial Results From the FMT National Registry
AU - Kelly, Colleen R.
AU - Yen, Eugene F.
AU - Grinspan, Ari M.
AU - Kahn, Stacy A.
AU - Atreja, Ashish
AU - Lewis, James D.
AU - Moore, Thomas A.
AU - Rubin, David T.
AU - Kim, Alison M.
AU - Serra, Sonya
AU - Nersesova, Yanina
AU - Fredell, Lydia
AU - Hunsicker, Dea
AU - McDonald, Daniel
AU - Knight, Rob
AU - Allegretti, Jessica R.
AU - Pekow, Joel
AU - Absah, Imad
AU - Hsu, Ronald
AU - Vincent, Jennifer
AU - Khanna, Sahil
AU - Tangen, Lyn
AU - Crawford, Carl V.
AU - Mattar, Mark C.
AU - Chen, Lea Ann
AU - Fischer, Monika
AU - Arsenescu, Razvan I.
AU - Feuerstadt, Paul
AU - Goldstein, Jonathan
AU - Kerman, David
AU - Ehrlich, Adam C.
AU - Wu, Gary D.
AU - Laine, Loren
N1 - Funding Information: Funding Research reported in this publication was supported by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health under Award Number R24AI118629. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. 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. Funding Information: The FMT National Registry is an ongoing, prospective, observational, multicenter registry of North American participants who receive FMT for any indication and began enrolling patients in December 2017. The registry is administered by the AGA with grant support from the National Institute of Allergy and Infectious Diseases (award R24AI118629). Partner organizations include the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition; the Infectious Diseases Society of America; and the Crohn’s & Colitis Foundation. Funding Information: 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. Funding Information: Funding Research reported in this publication was supported by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health under Award Number R24AI118629. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. Funding Information: To address these needs, the American Gastroenterological Association (AGA) Institute, in partnership with other professional organizations, has developed an FMT National Registry to collect clinical and patient-reported outcomes. This registry, funded by a grant from the National Institute of Allergy and Infectious Diseases, primarily aims to assess the short-term and long-term safety of FMT and other gut-related microbiota products. Secondary objectives include characterizing the effectiveness of FMT and other gut-related microbiota products, gathering information on FMT practice in North America, and promoting scientific investigation in FMT and the gut microbiome. Here we report on the first 259 participants enrolled in the FMT National Registry. Publisher Copyright: © 2021
PY - 2021/1
Y1 - 2021/1
N2 - 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.
AB - 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.
KW - Bacteriotherapy
KW - Microbiome
KW - Risk
UR - http://www.scopus.com/inward/record.url?scp=85097667856&partnerID=8YFLogxK
U2 - 10.1053/j.gastro.2020.09.038
DO - 10.1053/j.gastro.2020.09.038
M3 - Article
C2 - 33011173
AN - SCOPUS:85097667856
VL - 160
SP - 183-192.e3
JO - Gastroenterology
JF - Gastroenterology
SN - 0016-5085
IS - 1
ER -