Real-world Effectiveness of Fecal Microbiota Transplantation for First or Second Clostridioides difficile Infection

Sara Ellegaard Paaske; Simon Mark Dahl Baumwall; Tone Rubak; Frederik Hyllested Birn; Nina Rågård; Jens Kelsen; Mette Mejlby Hansen; Lise Svenningsen; Anne Lund Krarup; Christa Marie Culmbach Fernis; Anders Neumann; Anders Bergh Lødrup; Henning Glerup; Lars Vinter-Jensen; Morten Helms; Lise Tornvig Erikstrup; Anne Karmisholt Grosen; Susan Mikkelsen; Christian Erikstrup; Jens Frederik Dahlerup; Christian Lodberg Hvas

doi:10.1016/j.cgh.2024.05.038

Real-world Effectiveness of Fecal Microbiota Transplantation for First or Second Clostridioides difficile Infection

Sara Ellegaard Paaske^*, Simon Mark Dahl Baumwall, Tone Rubak, Frederik Hyllested Birn, Nina Rågård, Jens Kelsen, Mette Mejlby Hansen, Lise Svenningsen, Anne Lund Krarup, Christa Marie Culmbach Fernis, Anders Neumann, Anders Bergh Lødrup, Henning Glerup, Lars Vinter-Jensen, Morten Helms, Lise Tornvig Erikstrup, Anne Karmisholt Grosen, Susan Mikkelsen, Christian Erikstrup, Jens Frederik DahlerupChristian Lodberg Hvas

^*Corresponding author for this work

Research output: Contribution to journal/Conference contribution in journal/Contribution to newspaper › Journal article › Research › peer-review

2 Citations (Scopus)

Abstract

Background & Aims: Clostridioides difficile infection (CDI) is associated with high mortality. Fecal microbiota transplantation (FMT) is an established treatment for recurrent CDI, but its use for first or second CDI remains experimental. We aimed to investigate the effectiveness of FMT for first or second CDI in a real-world clinical setting. Methods: This multi-site Danish cohort study included patients with first or second CDI treated with FMT from June 2019 to February 2023. The primary outcome was cure of C. difficile-associated diarrhea (CDAD) 8 weeks after the last FMT treatment. Secondary outcomes included CDAD cure 1 and 8 weeks after the first FMT treatment and 90-day mortality following positive C. difficile test. Results: We included 467 patients, with 187 (40%) having their first CDI. The median patient age was 73 years (interquartile range [IQR], 58–82 years). Notably, 167 (36%) had antibiotic-refractory CDI, 262 (56%) had severe CDI, and 89 (19%) suffered from fulminant CDI. Following the first FMT treatment, cure of CDAD was achieved in 353 patients (76%; 95% confidence interval [CI], 71%–79%) at week 1. At week 8, 255 patients (55%; 95% CI, 50%–59%) maintained sustained effect. In patients without initial effect, repeated FMT treatments led to an overall cure of CDAD in 367 patients (79%; 95% CI, 75%–82%). The 90-day mortality was 10% (95% CI, 8%–14%). Conclusion: Repeated FMT treatments demonstrate high effectiveness in managing patients with first or second CDI. Forwarding FMT in CDI treatment guidelines could improve patient survival. ClinicalTrials.gov,

Original language	English
Journal	Clinical Gastroenterology and Hepatology
Volume	23
Issue	4
Pages (from-to)	602-611.e8
ISSN	1542-3565
DOIs	https://doi.org/10.1016/j.cgh.2024.05.038
Publication status	Published - Mar 2025

Keywords

Clostridioides difficile Infection (CDI)
Fecal Microbiota Transplantation (FMT)
Microbiome Therapies
Mortality
Real-world Evidence

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10.1016/j.cgh.2024.05.038

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Paaske, S. E., Baumwall, S. M. D., Rubak, T., Birn, F. H., Rågård, N., Kelsen, J., Hansen, M. M., Svenningsen, L., Krarup, A. L., Fernis, C. M. C., Neumann, A., Lødrup, A. B., Glerup, H., Vinter-Jensen, L., Helms, M., Erikstrup, L. T., Grosen, A. K., Mikkelsen, S., Erikstrup, C., ... Hvas, C. L. (2025). Real-world Effectiveness of Fecal Microbiota Transplantation for First or Second Clostridioides difficile Infection. Clinical Gastroenterology and Hepatology, 23(4), 602-611.e8. https://doi.org/10.1016/j.cgh.2024.05.038

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title = "Real-world Effectiveness of Fecal Microbiota Transplantation for First or Second Clostridioides difficile Infection",

abstract = "Background & Aims: Clostridioides difficile infection (CDI) is associated with high mortality. Fecal microbiota transplantation (FMT) is an established treatment for recurrent CDI, but its use for first or second CDI remains experimental. We aimed to investigate the effectiveness of FMT for first or second CDI in a real-world clinical setting. Methods: This multi-site Danish cohort study included patients with first or second CDI treated with FMT from June 2019 to February 2023. The primary outcome was cure of C. difficile-associated diarrhea (CDAD) 8 weeks after the last FMT treatment. Secondary outcomes included CDAD cure 1 and 8 weeks after the first FMT treatment and 90-day mortality following positive C. difficile test. Results: We included 467 patients, with 187 (40%) having their first CDI. The median patient age was 73 years (interquartile range [IQR], 58–82 years). Notably, 167 (36%) had antibiotic-refractory CDI, 262 (56%) had severe CDI, and 89 (19%) suffered from fulminant CDI. Following the first FMT treatment, cure of CDAD was achieved in 353 patients (76%; 95% confidence interval [CI], 71%–79%) at week 1. At week 8, 255 patients (55%; 95% CI, 50%–59%) maintained sustained effect. In patients without initial effect, repeated FMT treatments led to an overall cure of CDAD in 367 patients (79%; 95% CI, 75%–82%). The 90-day mortality was 10% (95% CI, 8%–14%). Conclusion: Repeated FMT treatments demonstrate high effectiveness in managing patients with first or second CDI. Forwarding FMT in CDI treatment guidelines could improve patient survival. ClinicalTrials.gov,",

keywords = "Clostridioides difficile Infection (CDI), Fecal Microbiota Transplantation (FMT), Microbiome Therapies, Mortality, Real-world Evidence",

author = "Paaske, {Sara Ellegaard} and Baumwall, {Simon Mark Dahl} and Tone Rubak and Birn, {Frederik Hyllested} and Nina R{\aa}g{\aa}rd and Jens Kelsen and Hansen, {Mette Mejlby} and Lise Svenningsen and Krarup, {Anne Lund} and Fernis, {Christa Marie Culmbach} and Anders Neumann and L{\o}drup, {Anders Bergh} and Henning Glerup and Lars Vinter-Jensen and Morten Helms and Erikstrup, {Lise Tornvig} and Grosen, {Anne Karmisholt} and Susan Mikkelsen and Christian Erikstrup and Dahlerup, {Jens Frederik} and Hvas, {Christian Lodberg}",

note = "Publisher Copyright: {\textcopyright} 2024 The Author(s)",

year = "2025",

month = mar,

doi = "10.1016/j.cgh.2024.05.038",

language = "English",

volume = "23",

pages = "602--611.e8",

journal = "Clinical Gastroenterology and Hepatology",

issn = "1542-3565",

publisher = "W.B. Saunders",

number = "4",

}

Paaske, SE, Baumwall, SMD, Rubak, T, Birn, FH, Rågård, N , Kelsen, J , Hansen, MM, Svenningsen, L, Krarup, AL, Fernis, CMC, Neumann, A, Lødrup, AB, Glerup, H, Vinter-Jensen, L, Helms, M, Erikstrup, LT, Grosen, AK , Mikkelsen, S , Erikstrup, C , Dahlerup, JF & Hvas, CL 2025, 'Real-world Effectiveness of Fecal Microbiota Transplantation for First or Second Clostridioides difficile Infection', Clinical Gastroenterology and Hepatology, vol. 23, no. 4, pp. 602-611.e8. https://doi.org/10.1016/j.cgh.2024.05.038

Real-world Effectiveness of Fecal Microbiota Transplantation for First or Second Clostridioides difficile Infection. / Paaske, Sara Ellegaard; Baumwall, Simon Mark Dahl; Rubak, Tone et al.
In: Clinical Gastroenterology and Hepatology, Vol. 23, No. 4, 03.2025, p. 602-611.e8.

Research output: Contribution to journal/Conference contribution in journal/Contribution to newspaper › Journal article › Research › peer-review

TY - JOUR

T1 - Real-world Effectiveness of Fecal Microbiota Transplantation for First or Second Clostridioides difficile Infection

AU - Paaske, Sara Ellegaard

AU - Baumwall, Simon Mark Dahl

AU - Rubak, Tone

AU - Birn, Frederik Hyllested

AU - Rågård, Nina

AU - Kelsen, Jens

AU - Hansen, Mette Mejlby

AU - Svenningsen, Lise

AU - Krarup, Anne Lund

AU - Fernis, Christa Marie Culmbach

AU - Neumann, Anders

AU - Lødrup, Anders Bergh

AU - Glerup, Henning

AU - Vinter-Jensen, Lars

AU - Helms, Morten

AU - Erikstrup, Lise Tornvig

AU - Grosen, Anne Karmisholt

AU - Mikkelsen, Susan

AU - Erikstrup, Christian

AU - Dahlerup, Jens Frederik

AU - Hvas, Christian Lodberg

PY - 2025/3

Y1 - 2025/3

N2 - Background & Aims: Clostridioides difficile infection (CDI) is associated with high mortality. Fecal microbiota transplantation (FMT) is an established treatment for recurrent CDI, but its use for first or second CDI remains experimental. We aimed to investigate the effectiveness of FMT for first or second CDI in a real-world clinical setting. Methods: This multi-site Danish cohort study included patients with first or second CDI treated with FMT from June 2019 to February 2023. The primary outcome was cure of C. difficile-associated diarrhea (CDAD) 8 weeks after the last FMT treatment. Secondary outcomes included CDAD cure 1 and 8 weeks after the first FMT treatment and 90-day mortality following positive C. difficile test. Results: We included 467 patients, with 187 (40%) having their first CDI. The median patient age was 73 years (interquartile range [IQR], 58–82 years). Notably, 167 (36%) had antibiotic-refractory CDI, 262 (56%) had severe CDI, and 89 (19%) suffered from fulminant CDI. Following the first FMT treatment, cure of CDAD was achieved in 353 patients (76%; 95% confidence interval [CI], 71%–79%) at week 1. At week 8, 255 patients (55%; 95% CI, 50%–59%) maintained sustained effect. In patients without initial effect, repeated FMT treatments led to an overall cure of CDAD in 367 patients (79%; 95% CI, 75%–82%). The 90-day mortality was 10% (95% CI, 8%–14%). Conclusion: Repeated FMT treatments demonstrate high effectiveness in managing patients with first or second CDI. Forwarding FMT in CDI treatment guidelines could improve patient survival. ClinicalTrials.gov,

AB - Background & Aims: Clostridioides difficile infection (CDI) is associated with high mortality. Fecal microbiota transplantation (FMT) is an established treatment for recurrent CDI, but its use for first or second CDI remains experimental. We aimed to investigate the effectiveness of FMT for first or second CDI in a real-world clinical setting. Methods: This multi-site Danish cohort study included patients with first or second CDI treated with FMT from June 2019 to February 2023. The primary outcome was cure of C. difficile-associated diarrhea (CDAD) 8 weeks after the last FMT treatment. Secondary outcomes included CDAD cure 1 and 8 weeks after the first FMT treatment and 90-day mortality following positive C. difficile test. Results: We included 467 patients, with 187 (40%) having their first CDI. The median patient age was 73 years (interquartile range [IQR], 58–82 years). Notably, 167 (36%) had antibiotic-refractory CDI, 262 (56%) had severe CDI, and 89 (19%) suffered from fulminant CDI. Following the first FMT treatment, cure of CDAD was achieved in 353 patients (76%; 95% confidence interval [CI], 71%–79%) at week 1. At week 8, 255 patients (55%; 95% CI, 50%–59%) maintained sustained effect. In patients without initial effect, repeated FMT treatments led to an overall cure of CDAD in 367 patients (79%; 95% CI, 75%–82%). The 90-day mortality was 10% (95% CI, 8%–14%). Conclusion: Repeated FMT treatments demonstrate high effectiveness in managing patients with first or second CDI. Forwarding FMT in CDI treatment guidelines could improve patient survival. ClinicalTrials.gov,

KW - Clostridioides difficile Infection (CDI)

KW - Fecal Microbiota Transplantation (FMT)

KW - Microbiome Therapies

KW - Mortality

KW - Real-world Evidence

UR - http://www.scopus.com/inward/record.url?scp=85202073687&partnerID=8YFLogxK

U2 - 10.1016/j.cgh.2024.05.038

DO - 10.1016/j.cgh.2024.05.038

M3 - Journal article

C2 - 38871148

AN - SCOPUS:85202073687

SN - 1542-3565

VL - 23

SP - 602-611.e8

JO - Clinical Gastroenterology and Hepatology

JF - Clinical Gastroenterology and Hepatology

IS - 4

ER -

Real-world Effectiveness of Fecal Microbiota Transplantation for First or Second Clostridioides difficile Infection

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