Key takeaways:
- FMT appeared as efficient as vancomycin in curing first-time C. difficile an infection.
- Findings present FMT has potential as a protected, viable first-line remedy with out antibiotic pretreatment.
Fecal microbiota transplantation was not inferior to vancomycin for the remedy of major Clostridioides difficile an infection, suggesting it may very well be a first-line possibility, in accordance with analysis printed in Annals of Inside Medication.
“Our trial is the primary giant, section 3 randomized trial in first-time, major C. difficile infections evaluating FMT to antibiotics, the beneficial first-line remedy,” Frederik Emil Juul, MD, PhD, postdoctoral researcher at College of Oslo, instructed Healio. “We demonstrated that FMT is not less than as efficient as antibiotics by way of remedy efficacy, and numerically, FMT truly appears to be higher than antibiotics.”
Knowledge had been derived from Juul F, et al. Ann Intern Med. 2025;doi:10.7326/ANNALS-24-03285.
FMT has been established as a remedy possibility for recurrent C. difficile an infection, whereas antibiotics reminiscent of vancomycin or fidaxomicin are beneficial first-line remedy.
Extended antibiotic remedy is dear, nonetheless, has antagonistic results and contributes to antibiotic resistance, in accordance with Juul and colleagues, who aimed to review FMT’s use as a major remedy, because it addresses the reason for an infection.
They carried out a multicenter, open-label, assessor-blinded, noninferiority trial of adults with major C. difficile an infection and no earlier prognosis of an infection inside the previous one year.
The researchers randomly assigned sufferers to obtain one FMT enema with out antibiotic pretreatment (n = 51; median age, 70 years; 62.8% girls) or 125 mg of oral vancomycin 4 instances every day for 10 days (n = 49; median age, 71 years; 53.1% girls).
Medical treatment, outlined as fewer than three stools per day or agency stools for not less than 48 hours at day 14, occurred in 70.6% of the FMT group and 77.6% of the vancomycin group at day 14.
The researchers outlined noninferiority as a medical treatment fee with FMT greater than 25 share factors decrease than with vancomycin.
Two-thirds (66.7%; 95% CI, 52.1%–79.2%) of the FMT group achieved the research’s major endpoint of medical treatment with out recurrence inside 60 days in contrast with 61.2% (95% CI, 46.2%-74.8%) of the vancomycin group — a danger distinction of 5.4 share factors (P < .001 for non-inferiority).
Further remedy was given to 11 sufferers within the FMT group and 4 within the vancomycin group, indicating 78.4% (95% CI, 64.7%-88.7%) of the FMT group and 61.2% (95% CI, 46.2%-74.8%) of the vancomycin group achieved the research’s secondary endpoint, outlined as medical treatment at day 14, with or with out extra remedy. The chance distinction was 17.2 share factors (P < .001 for non-inferiority).
Hostile occasions had been comparable between the 2 teams and none had been associated to the remedy.
Seven sufferers died throughout the research interval — two within the FMT group and 5 within the vancomycin group. One demise in every group was as a result of recurrent C. difficile an infection.
Frederik Emil Juul
“Based mostly on the trial outcomes, we conclude that FMT might have a job in major C. difficile infections, not solely after a number of recurrences,” Juul instructed Healio. “Our outcomes present that antibiotic pretreatment will not be obligatory to attain medical treatment in major C. difficile infections. With rigorous FMT donor screening and remedy preparation, FMT is protected and not less than as efficient as antibiotics.”
For extra info:
Frederik Emil Juul, MD, PhD, might be reached at f.e.juul@medisin.uio.no.
Sources/Disclosures
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Disclosures:
Juul reviews presenting for Tillotts Pharma. Please see the research for all different authors’ related monetary disclosures.
