WEDNESDAY, June 25, 2025 (HealthDay News) — Fecal microbiota transplantation (FMT) could be considered as first-line therapy for primary Clostridioides difficile infection (CDI), according to a study published online June 17 in the Annals of Internal Medicine.

Frederik Emil Juul, M.D., Ph.D., from Oslo University Hospital in Norway, and colleagues examined the efficacy and safety of FMT in primary CDI in a randomized, open-label, noninferiority trial. Adults with CDI and no previous CDI within 365 days before enrollment were randomly assigned to receive FMT without antibiotic pretreatment or oral vancomycin, 125 mg four times daily for 10 days.

The researchers found that clinical cure and no disease recurrence within 60 days without additional treatment was observed in 66.7 percent of 51 patients receiving FMT versus 61.2 percent of 49 patients receiving vancomycin (difference, 5.4 percentage points; 95.2 percent confidence interval, −13.5 to 24.4 percentage points; P for noninferiority <0.001). Additional C. difficile treatment was received by 11 and four patients in the FMT and vancomycin groups, respectively. Clinical cure at day 14 and no recurrence with or without additional treatment was observed in 78.4 and 61.2 percent of patients receiving FMT and vancomycin, respectively. The groups did not have any significant differences in adverse events.

“FMT even showed a 5.4 percent numerical superiority to vancomycin, which, although not statistically significant, indicates that FMT has the potential to change the current practice of antibiotic therapy and may establish FMT as a first-line treatment for primary CDI,” the authors write.

Several authors disclosed ties to the pharmaceutical industry.

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