Ann Intern Med

Fecal microbiota transplantation noninferior to vancomycin for primary C. difficile infection

June 23, 2025

Study details: This multicenter, randomized, open-label, noninferiority trial enrolled 104 adults in Norway with primary Clostridioides difficile infection (CDI), defined as ≥3 loose stools daily and positive stool toxin, with no CDI in the prior year. Patients were randomized to receive either a single fecal microbiota transplantation (FMT) without antibiotic pretreatment, or oral vancomycin 125 mg qid for 10 days. The primary endpoint was clinical cure (firm stools or <3 bowel movements daily at day 14) and no recurrence within 60 days, without additional CDI therapy.

Results: Among 100 patients analyzed, the rate of clinical cure without recurrence at 60 days was 66.7% of the FMT group vs. 61.2% of the vancomycin group (difference, 5.4 percentage points; 95.2% CI, -13.5 to 24.4; P for noninferiority <0.001). Rates of adverse events were similar between groups. More patients in the FMT group required additional CDI treatment (11 vs. 4).

Clinical impact: The findings suggest that FMT is noninferior to vancomycin as first-line therapy for primary CDI, supporting its consideration in select patients. Further studies and guideline updates are warranted to clarify FMT’s role in primary CDI.

Source:

Juul FE, et al. (2025, June 17). Ann Intern Med. Fecal Microbiota Transplantation Versus Vancomycin for Primary Clostridioides difficile Infection: A Randomized Controlled Trial.https://pubmed.ncbi.nlm.nih.gov/40523286/