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Fecal Microbiota Transplantation Is Superior to Fidaxomicin for Treatment of Recurrent Clostridium difficile Infection
Open accessAbstract
BACKGROUND & AIMS: Fecal microbiota transplantation (FMT) is recommended for treatment of recurrent Clostridium difficile infection (rCDI). We performed a single-center randomized trial to compare the effects of FMT with those of fidaxomicin and vancomycin. METHODS: We studied consecutive adults with rCDI seen at a gastroenterology clinic in Denmark from April 5, 2016 through June 10, 2018. Patients were randomly assigned to a group that received FMT, applied by colonoscopy or nasojejunal tube, after 4-10 days of vancomycin (125 mg 4 times daily; FMTv; n = 24), 10 days of fidaxomicin (200 mg twice daily; n = 24), or 10 days of vancomycin (125 mg 4 times daily; n = 16). Patients who had rCDI after this course of treatment and patients who could not be randomly assigned to groups were offered rescue FMTv. The primary outcome was combined clinical resolution and a negative result from a polymerase chain reaction test for Clostridium difficile (CD) toxin 8 weeks after the allocated treatment. Secondary end points included clinical resolution at week 8. RESULTS: All 64 patients received their assigned treatment. The combination of clinical resolution and negative results from the test for CD were observed in 17 patients given FMTv (71%), 8 patients given fidaxomicin (33%), and 3 patients given vancomycin (19%; P = .009 for FMTv vs fidaxomicin; P = .001 for FMTv vs vancomycin; P = .31 for fidaxomicin vs vancomycin). Clinical resolution was observed in 22 patients given FMTv (92%), 10 patients given fidaxomicin (42%), and 3 patients given vancomycin (19%; P = .0002; P < .0001; P = .13). Results did not differ significantly between patients who received FMTv as their initial therapy and patients who received rescue FMTv. There was 1 serious adverse event that might have been related to FMTv. CONCLUSIONS: In a randomized trial of patients with rCDI, we found the FMTv combination superior to fidaxomicin or vancomycin based on end points of clinical and microbiological resolution or clinical resolution alone. ClinicalTrials.gov, number NCT02743234; EudraCT, j.no 2015-003004-24.
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“has proven to be a reliable therapeutic alternative to the antibiotics vancomycin 6,7 and fidaxomicin. 8”
From Key determinants of success in fecal microbiota transplantation: From microbiome to clinic (2023) · cites this paper as [8]
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Metadata
- Authors
- Hvas, C. L., Dahl Jørgensen, S. M., Jørgensen, S. P., Storgaard, M., Lemming, L., Hansen, M. M., Erikstrup, C., & Dahlerup, J. F.
- Affiliations
- Aarhus University Hospital (DK)
- Corresponding author
- Hvas, Christian Lodberg
- ORCID
- Venue
- Gastroenterology
- Publisher
- Elsevier BV
- Published
- 2019-04
- Volume
- 156
- Issue
- 5
- Pages
- 1324-1332.e3
- ISSN
- 0016-5085 (ISSN-L)
- OpenAlex
- W2907954911
- Cited by
- 390
- References
- 54
- Citations by year
- 2026: 36 · 2025: 44 · 2024: 58 · 2023: 58 · 2022: 57 · 2021: 46 · 2020: 57 · 2019: 33
- FWCI
- 36.80
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Gastroenterology (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- Funders
- Aalborg Universitet
- Topics
- Health Sciences › Medicine › Infectious Diseases › Clostridium difficile and Clostridium perfringens research
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Gut microbiota and health
- Health Sciences › Medicine › Gastroenterology › Gastrointestinal motility and disorders
- Keywords
- fecal microbiota transplantation, recurrent Clostridium difficile infection, fidaxomicin, vancomycin, clinical resolution, treatment comparison, adverse events, Clostridium difficile infection
- MeSH terms
- Fecal Microbiota Transplantation, Fidaxomicin, Adult, Aged, Aged, 80 and over, Anti-Bacterial Agents, Clostridium Infections, Denmark, Female, Humans, Male, Middle Aged, Recurrence, Remission Induction, Time Factors, Vancomycin, Clostridioides difficile, Treatment Outcome, Young Adult
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