Fecal Microbiota Transplantation Versus Vancomycin for Primary <i>Clostridioides difficile</i> Infection

Abstract

BACKGROUND: 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: 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: 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.