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Updated: Sep 19, 2025
Fecal Microbiota Transplantation via Colonoscopy for Recurrent C. difficile Infection
Published on: December 8, 2014
Fecal Microbiota Transplantation Versus Vancomycin for Primary Clostridioides difficile Infection : A Randomized
Frederik Emil Juul1, Michael Bretthauer2, Peter H Johnsen3
1Clinical Effectiveness Research Group, Oslo University Hospital, Oslo, Norway; Clinical Effectiveness Research Group, University of Oslo, Oslo, Norway; and Vestre Viken Bærum Hospital, Gjettum, Norway (F.E.J.).
Background:
Fecal microbiota transplantation (FMT) is recommended for recurrent Clostridioides difficile 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 (C difficile 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]; P 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 C difficile 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.
Insights
Fecal microbiota transplantation (FMT) shows promise as a first-line treatment for primary Clostridioides difficile infection (CDI), demonstrating comparable efficacy and safety to standard vancomycin therapy. This study suggests FMT could be a viable alternative for initial CDI management.
Area of Science:
- Gastroenterology
- Infectious Diseases
- Microbiome Research
Background:
- Fecal microbiota transplantation (FMT) is a recommended treatment for recurrent Clostridioides difficile infection (CDI).
- The efficacy and safety of FMT for primary (initial) CDI are not well-established.
- This study aimed to clarify the role of FMT in treating patients with their first episode of CDI.
Purpose of the Study:
- To investigate the efficacy and safety of FMT as a first-line treatment for primary Clostridioides difficile infection (CDI).
- To compare FMT without antibiotic pretreatment to standard oral vancomycin therapy for primary CDI.
- To determine if FMT is noninferior to vancomycin for achieving clinical cure and preventing recurrence in primary CDI.
Main Methods:
- A randomized, open-label, multicenter, noninferiority trial was conducted involving adult patients diagnosed with primary CDI.
- Participants were assigned to receive either FMT without antibiotic pretreatment or oral vancomycin for 10 days.
- The primary endpoint was clinical cure, defined as firm stools or fewer than three bowel movements daily at day 14, with no disease recurrence within 60 days, using only the assigned treatment.
Main Results:
- Of 104 randomized patients, 100 were analyzed. Clinical cure and no recurrence within 60 days without additional treatment occurred in 66.7% of the FMT group versus 61.2% of the vancomycin group.
- FMT was found to be noninferior to vancomycin for primary CDI treatment (P for noninferiority < 0.001).
- When considering treatment with or without additional therapies, FMT showed a higher cure rate (78.4%) compared to vancomycin (61.2%), with no significant difference in adverse events between the groups.
Conclusions:
- Fecal microbiota transplantation (FMT) may be considered as a first-line therapy for patients with primary Clostridioides difficile infection (CDI).
- The study results support the use of FMT as an effective and safe alternative to vancomycin for initial CDI treatment.
- Further research may explore optimal protocols and long-term outcomes of FMT in primary CDI.
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