Effectiveness and Safety of Colonic and Capsule Fecal Microbiota Transplantation for Recurrent Clostridioides difficile Infection
Copyright © 2023 AGA Institute. Published by Elsevier Inc. All rights reserved..
BACKGROUND & AIMS: Fecal microbiota transplantation (FMT) emerged as rescue treatment for multiply recurrent Clostridioides difficile infections (rCDIs) nonresponsive to standard therapy. However, estimation of FMT efficacy varies among different protocols and formulations, while placebo-controlled clinical trials have excluded most rCDI patients because of medical comorbidities. This study aimed to determine the safety and effectiveness of capsule FMT (cap-FMT) and colonoscopy FMT (colo-FMT) for rCDI using standardized products in a large, multicenter, prospective, real-world cohort.
METHODS: Clinical outcomes and adverse events after FMT performed for rCDI at 6 sites were captured in a prospective registry. FMT was performed using 1 of 2 standardized formulations of microbiota manufactured by the University of Minnesota Microbiota Therapeutics Program, freeze-dried/encapsulated or frozen-thawed/liquid. The FMT administration route was determined by the treating physician. The rCDI cure rate was assessed at 1 and 2 months. Safety data were collected within the first 72 hours and at 1 and 2 months. Logistic regression was used to investigate factors associated with FMT failure.
RESULTS: A total of 301 FMTs were performed in 269 unique patients. Two-thirds were cap-FMT. CDI cure rates were 86% (95% CI, 82%-90%) at 1 month and 81% (95% CI, 75%-86%) at 2 months. There was no difference in the 1-month or 2-month cure rate between cap-FMT and colo-FMT. Cap-FMT recipients were older and less likely to be immunosuppressed or have inflammatory bowel disease. Patient factors of older age and hemodialysis were associated with FMT failure by 2 months on multivariate logistic regression. In addition, post-FMT antibiotic use was associated with FMT failure at 2 months. One serious adverse event was related to colonoscopy (aspiration pneumonia), otherwise no new safety signals were identified.
CONCLUSIONS: Cap-FMT using freeze-dried capsules has a similar safety and effectiveness profile compared with colo-FMT, without the procedural risks of colonoscopy. Although highly effective overall, patient selection is a key factor to optimizing FMT success.
| Errataetall: |
CommentIn: Clin Gastroenterol Hepatol. 2023 Aug;21(9):2432. - PMID 36307057 |
|---|---|
| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2023 |
|---|---|
| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:21 |
|---|---|
| Enthalten in: |
Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association - 21(2023), 5 vom: 27. Mai, Seite 1330-1337.e2 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Vaughn, Byron P [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
Clostridioides difficile Infection |
|---|
| Anmerkungen: |
Date Completed 25.04.2023 Date Revised 05.02.2024 published: Print-Electronic CommentIn: Clin Gastroenterol Hepatol. 2023 Aug;21(9):2432. - PMID 36307057 Citation Status MEDLINE |
|---|
| doi: |
10.1016/j.cgh.2022.09.008 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM346433665 |
|---|
| LEADER | 01000caa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM346433665 | ||
| 003 | DE-627 | ||
| 005 | 20240206231832.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231226s2023 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1016/j.cgh.2022.09.008 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1282.xml |
| 035 | |a (DE-627)NLM346433665 | ||
| 035 | |a (NLM)36126907 | ||
| 035 | |a (PII)S1542-3565(22)00880-1 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Vaughn, Byron P |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Effectiveness and Safety of Colonic and Capsule Fecal Microbiota Transplantation for Recurrent Clostridioides difficile Infection |
| 264 | 1 | |c 2023 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 25.04.2023 | ||
| 500 | |a Date Revised 05.02.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a CommentIn: Clin Gastroenterol Hepatol. 2023 Aug;21(9):2432. - PMID 36307057 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2023 AGA Institute. Published by Elsevier Inc. All rights reserved. | ||
| 520 | |a BACKGROUND & AIMS: Fecal microbiota transplantation (FMT) emerged as rescue treatment for multiply recurrent Clostridioides difficile infections (rCDIs) nonresponsive to standard therapy. However, estimation of FMT efficacy varies among different protocols and formulations, while placebo-controlled clinical trials have excluded most rCDI patients because of medical comorbidities. This study aimed to determine the safety and effectiveness of capsule FMT (cap-FMT) and colonoscopy FMT (colo-FMT) for rCDI using standardized products in a large, multicenter, prospective, real-world cohort | ||
| 520 | |a METHODS: Clinical outcomes and adverse events after FMT performed for rCDI at 6 sites were captured in a prospective registry. FMT was performed using 1 of 2 standardized formulations of microbiota manufactured by the University of Minnesota Microbiota Therapeutics Program, freeze-dried/encapsulated or frozen-thawed/liquid. The FMT administration route was determined by the treating physician. The rCDI cure rate was assessed at 1 and 2 months. Safety data were collected within the first 72 hours and at 1 and 2 months. Logistic regression was used to investigate factors associated with FMT failure | ||
| 520 | |a RESULTS: A total of 301 FMTs were performed in 269 unique patients. Two-thirds were cap-FMT. CDI cure rates were 86% (95% CI, 82%-90%) at 1 month and 81% (95% CI, 75%-86%) at 2 months. There was no difference in the 1-month or 2-month cure rate between cap-FMT and colo-FMT. Cap-FMT recipients were older and less likely to be immunosuppressed or have inflammatory bowel disease. Patient factors of older age and hemodialysis were associated with FMT failure by 2 months on multivariate logistic regression. In addition, post-FMT antibiotic use was associated with FMT failure at 2 months. One serious adverse event was related to colonoscopy (aspiration pneumonia), otherwise no new safety signals were identified | ||
| 520 | |a CONCLUSIONS: Cap-FMT using freeze-dried capsules has a similar safety and effectiveness profile compared with colo-FMT, without the procedural risks of colonoscopy. Although highly effective overall, patient selection is a key factor to optimizing FMT success | ||
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a Clostridioides difficile Infection | |
| 650 | 4 | |a Colitis | |
| 650 | 4 | |a Fecal Microbiota Transplant | |
| 650 | 4 | |a Microbiome | |
| 700 | 1 | |a Fischer, Monika |e verfasserin |4 aut | |
| 700 | 1 | |a Kelly, Colleen R |e verfasserin |4 aut | |
| 700 | 1 | |a Allegretti, Jessica R |e verfasserin |4 aut | |
| 700 | 1 | |a Graiziger, Carolyn |e verfasserin |4 aut | |
| 700 | 1 | |a Thomas, Juana |e verfasserin |4 aut | |
| 700 | 1 | |a McClure, Emma |e verfasserin |4 aut | |
| 700 | 1 | |a Kabage, Amanda J |e verfasserin |4 aut | |
| 700 | 1 | |a Khoruts, Alexander |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association |d 2003 |g 21(2023), 5 vom: 27. Mai, Seite 1330-1337.e2 |w (DE-627)NLM147178851 |x 1542-7714 |7 nnns |
| 773 | 1 | 8 | |g volume:21 |g year:2023 |g number:5 |g day:27 |g month:05 |g pages:1330-1337.e2 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1016/j.cgh.2022.09.008 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 21 |j 2023 |e 5 |b 27 |c 05 |h 1330-1337.e2 | ||