Randomised clinical trial: faecal microbiota transplantation by colonoscopy vs. vancomycin for the treatment of recurrent Clostridium difficile infection
Open accessAbstract
BACKGROUND: Faecal microbiota transplantation (FMT) from healthy donors is considered an effective treatment against recurrent Clostridium difficile infection. AIM: To study the effect of FMT via colonoscopy in patients with recurrent C. difficile infection compared to the standard vancomycin regimen. METHODS: In an open-label, randomised clinical trial, we assigned subjects with recurrent C. difficile infection to receive: FMT, short regimen of vancomycin (125 mg four times a day for 3 days), followed by one or more infusions of faeces via colonoscopy; or vancomycin, vancomycin 125 mg four times daily for 10 days, followed by 125-500 mg/day every 2-3 days for at least 3 weeks. The latter treatment did not include performing colonoscopy. The primary end point was the resolution of diarrhoea related to C. difficile infection 10 weeks after the end of treatments. RESULTS: The study was stopped after a 1-year interim analysis. Eighteen of the 20 patients (90%) treated by FMT exhibited resolution of C. difficile-associated diarrhoea. In FMT, five of the seven patients with pseudomembranous colitis reported a resolution of diarrhoea. Resolution of C. difficile infection occurred in 5 of the 19 (26%) patients in vancomycin (P < 0.0001). No significant adverse events were observed in either of the study groups. CONCLUSIONS: Faecal microbiota transplantation using colonoscopy to infuse faeces was significantly more effective than vancomycin regimen for the treatment of recurrent C. difficile infection. The delivery of donor faeces via colonoscopy has the potential to optimise the treatment strategy in patients with pseudomembranous colitis.
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FMT has proven to be a reliable therapeutic alternative to the antibiotics vancomycin and fidaxomicin for rCDI.
“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 [6]
In an early randomized trial of patients with CDI, patients with pseudomembranous colitis were less likely to be cured after a single FMT.
“In an early randomized trial of patients with CDI, Cammarota and colleagues observed that patients with pseudomembranous colitis were less likely to be cured after a single FMT.”
From Key determinants of success in fecal microbiota transplantation: From microbiome to clinic (2023) · cites this paper as [6]
Repeating FMT after a failure is a well-established way to increase overall efficacy rates in patients with CDI.
“Repeating FMT after a failure is a well-established way to increase overall efficacy rates in patients with CDI.”
From Key determinants of success in fecal microbiota transplantation: From microbiome to clinic (2023) · cites this paper as [6]
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- Authors
- Cammarota, G., Masucci, L., Ianiro, G., Bibbò, S., Dinoi, G., Costamagna, G., Sanguinetti, M., & Gasbarrini, A.
- Affiliations
- Università Cattolica del Sacro Cuore (IT)
- Corresponding author
- Cammarota, G.
- ORCID
- Venue
- Alimentary Pharmacology & Therapeutics
- Publisher
- Wiley
- Published
- 2015-03
- Volume
- 41
- Issue
- 9
- Pages
- 835-843
- ISSN
- 0269-2813 (ISSN-L)
- 1365-2036
- OpenAlex
- W2119114528
- Cited by
- 558
- References
- 33
- Citations by year
- 2026: 15 · 2025: 27 · 2024: 39 · 2023: 40 · 2022: 42 · 2021: 57 · 2020: 71 · 2019: 68 · 2018: 65 · 2017: 60 · 2016: 54 · 2015: 20
- FWCI
- 51.72
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Alimentary Pharmacology & Therapeutics (publishedVersion)
- PubMed (publishedVersion)
- Funders
- The study was funded by the Catholic University of Rome (Line D-1.)
- 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, vancomycin, colonoscopy, pseudomembranous colitis, treatment efficacy
- MeSH terms
- Adult, Aged, Aged, 80 and over, Clostridium Infections, Colonoscopy, Diarrhea, Enterocolitis, Pseudomembranous, Feces, Female, Humans, Male, Middle Aged, Vancomycin, Clostridioides difficile, Treatment Outcome, Microbiota
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