COLONIZE
Trial question
Is fecal microbiota transplantation noninferior to vancomycin in patients with primary C. difficile infection?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
58.0% female
42.0% male
N = 100
100 patients (58 female, 42 male).
Inclusion criteria: adult patients with primary C. difficile infection.
Key exclusion criteria: other stool pathogens known to cause diarrhea; ongoing antibiotic treatment for other infections that could not be stopped; IBD; microscopic colitis; life expectancy ≤ 3 months; serious immunodeficiency; inability to comply with protocol requirements; need for intensive care at enrolment; IBS; pregnancy/lactation; toxic megacolon or ileus; total or subtotal colectomy; ileostomy or colostomy.
Interventions
N=51 fecal microbiota transplantation (fecal microbiota transplantation enema administered within 24 hours of randomization).
N=49 vancomycin (at a dose of 125 mg QID for 10 days).
Primary outcome
Clinical cure at day 14 and no disease recurrence within 60 days after start of treatment
66.7%
61.2%
66.7 %
50.0 %
33.4 %
16.7 %
0.0 %
Fecal microbiota
transplantation
Vancomycin
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in clinical cure at day 14 and no disease recurrence within 60 days after the start of treatment (66.7% vs. 61.2%; AD 5.4%, 95% CI -13.5 to 24.4).
Secondary outcomes
No significant difference in clinical cure at day 14 with or without additional treatment and no disease recurrence within 60 days after the start of treatment (78.4% vs. 61.2%; AD 17.2%, 95% CI -0.7 to 35.1).
Safety outcomes
No significant difference in adverse and serious adverse events.
Conclusion
In adult patients with primary C. difficile infection, fecal microbiota transplantation was noninferior to vancomycin with respect to clinical cure at day 14 and no disease recurrence within 60 days after the start of treatment.
Reference
Frederik Emil Juul, Michael Bretthauer, Peter H Johnsen et al. Fecal Microbiota Transplantation Versus Vancomycin for Primary Clostridioides difficile Infection : A Randomized Controlled Trial. Ann Intern Med. 2025 Jun 17. Online ahead of print.
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