Randomised clinical trial: faecal microbiota transplantation by colonoscopy plus vancomycin for the treatment of severe refractory Clostridium difficile infection—single versus multiple infusions

Ianiro, G.; Masucci, L.; Quaranta, G.; Simonelli, C.; Lopetuso, L. R.; Sanguinetti, M.; Gasbarrini, A.; Cammarota, G.

doi:10.1111/apt.14816

Cited by 152Clostridium difficile and Clostridium perfringens researchGut microbiota and healthGastrointestinal motility and disorders

Randomised clinical trial: faecal microbiota transplantation by colonoscopy plus vancomycin for the treatment of severe refractory Clostridium difficile infection—single versus multiple infusions

Ianiro, G., Masucci, L., Quaranta, G., Simonelli, C., Lopetuso, L. R., Sanguinetti, M., Gasbarrini, A., Cammarota, G.·2018·Alimentary Pharmacology & Therapeutics

DOI 10.1111/apt.14816

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Abstract

BACKGROUND: Faecal microbiota transplantation (FMT) is a highly effective treatment against recurrent Clostridium difficile infection. Far less evidence exists on the efficacy of FMT in treating severe Clostridium difficile infection refractory to antibiotics. AIM: To compare the efficacy of two FMT-based protocols associated with vancomycin in curing subjects with severe Clostridium difficile infection refractory to antibiotics. METHODS: Subjects with severe Clostridium difficile infection refractory to antibiotics were randomly assigned to one of the two following treatment arms: (1) FMT-S, including a single faecal infusion via colonoscopy followed by a 14-day vancomycin course, (2) FMT-M, including multiple faecal infusions plus a 14-day vancomycin course. In the FMT-M group, all subjects received at least two infusions, while those with pseudomembranous colitis underwent further infusions until the disappearance of pseudomembranes. The primary outcome was the cure of refractory severe Clostridium difficile infection. RESULTS: Fifty six subjects, 28 in each treatment arm, were enrolled. Twenty one patients in the FMT-S group and 28 patients in the FMT-M group were cured (75% vs 100%, respectively, both in per protocol and intention-to-treat analyses; P = 0.01). No serious adverse events associated with any of the two treatment protocols were observed. CONCLUSIONS: A pseudomembrane-driven FMT protocol consisting of multiple faecal infusions and concomitant vancomycin was significantly more effective than a single faecal transplant followed by vancomycin in curing severe Clostridium difficile infection refractory to antibiotics. Clinical-Trials.gov registration number: NCT03427229.

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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 [9]

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Authors: Ianiro, G., Masucci, L., Quaranta, G., Simonelli, C., Lopetuso, L. R., Sanguinetti, M., Gasbarrini, A., & Cammarota, G.
Affiliations: Università Cattolica del Sacro Cuore (IT)
Corresponding author: Cammarota, G.
ORCID: Ianiro, G.
Masucci, L.
Quaranta, G.
Lopetuso, L. R.
Sanguinetti, M.
Gasbarrini, A.
Cammarota, G.
Venue: Alimentary Pharmacology & Therapeutics
Publisher: Wiley
Published: 2018-05-30
Volume: 48
Issue: 2
Pages: 152-159
ISSN: 0269-2813 (ISSN-L)
1365-2036
DOI: 10.1111/apt.14816
OpenAlex: W2806192813
Cited by: 152
References: 29
Citations by year: 2026: 9 · 2025: 12 · 2024: 17 · 2023: 15 · 2022: 16 · 2021: 27 · 2020: 28 · 2019: 25 · 2018: 3
FWCI: 15.68
Type: journal article
Language: en
Open access: closed
Licence: onlinelibrary.wiley.com/termsAndConditions#vor (vor)
Locations: Alimentary Pharmacology & Therapeutics (publishedVersion)
PubMed (publishedVersion)
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, Clostridium difficile infection, refractory infection, vancomycin, colonoscopy, pseudomembranous colitis, treatment efficacy
MeSH terms: Fecal Microbiota Transplantation, Aged, Aged, 80 and over, Anti-Bacterial Agents, Clostridium Infections, Colonoscopy, Combined Modality Therapy, Enterocolitis, Pseudomembranous, Feces, Female, Humans, Male, Middle Aged, Severity of Illness Index, Vancomycin, Clostridioides difficile, Treatment Outcome, Drug Resistance, Bacterial

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Randomised clinical trial: faecal microbiota transplantation by colonoscopy plus vancomycin for the treatment of severe refractory Clostridium difficile infection—single versus multiple infusions

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