Fecal Microbiota Transplantation Versus Vancomycin for Primary Infection : A Randomized Controlled Trial.

Background: Fecal microbiota transplantation (FMT) is recommended for recurrent infection (CDI), but its role in primary CDI is unclear.

Objective: To investigate the efficacy and safety of FMT in primary CDI.

Design: Randomized, open-label, noninferiority, multicenter trial. (ClinicalTrials.gov: NCT03796650).

Setting: Hospitals and primary care facilities in Norway.

Patients: Adults with CDI ( toxin in stool and ≥3 loose stools daily) and no previous CDI within 365 days before enrollment.

Intervention: FMT without antibiotic pretreatment versus oral vancomycin, 125 mg 4 times daily for 10 days.

Measurements: The primary end point was clinical cure (firm stools or <3 bowel movements daily) at day 14 and no disease recurrence within 60 days with the assigned treatment alone.

Results: Of 104 randomly assigned patients, 100 received FMT or the first dose of vancomycin and were eligible for analysis. Clinical cure and no disease recurrence within 60 days without additional treatment was observed in 34 of 51 patients (66.7%) with FMT versus 30 of 49 (61.2%) with vancomycin (difference, 5.4 percentage points [95.2% CI, -13.5 to 24.4 percentage points]; for noninferiority < 0.001, rejecting the hypothesis that response to FMT is 25 percentage points lower than response to vancomycin). Eleven patients in the FMT group and 4 in the vancomycin group had additional treatment. Clinical cure at day 14 and no recurrence with or without additional treatment was observed in 40 of 51 patients (78.4%) with FMT and 30 of 49 (61.2%) with vancomycin (difference, 17.2 percentage points [95.2% CI, -0.7 to 35.1 percentage points]). No significant differences in adverse events were observed between groups.

Limitations: Open-label design and reliance on clinical end points.

Conclusion: FMT may be considered as first-line therapy in primary CDI.

Primary Funding Source: South-East Norway Health Trust.