"Fecal Microbiota Transplantation for Recurrent Clostridium difficile Infection".The New England Journal of Medicine. 2013. 368(5):407-415.PubMed•Full text•PDFContents

1Clinical Question
2Bottom Line
3Major Points
4Guidelines
5Design
6Population
6.1Inclusion Criteria
6.2Exclusion Criteria
6.3Baseline Characteristics
7Interventions
8Outcomes
8.1Primary Outcomes
8.2Secondary Outcomes
9Funding
10Further Reading

Clinical Question

In patients with recurrent Clostridium difficile infection, is duodenal infusion of donor feces more effective than vancomycin therapy?

Bottom Line

Duodenal infusion of donor feces (fecal microbiota transplantation) is significantly more effective for the treatment of recurrent C. difficile infection than vancomycin therapy.

Major Points

Recurrent C. difficile infection poses a significant treatment challenge, with high failure rates for standard antibiotic therapy. Fecal microbiota transplantation (FMT) has emerged as a potential solution with promising results in case series and uncontrolled studies. This trial provides strong evidence supporting the use of FMT in patients with recurrent C. difficile infection.

Guidelines

As of the knowledge cutoff for this summary, specific guidelines for fecal microbiota transplantation were not described in the source text.

Design

- Multicenter, open-label, randomized, controlled trial
- N=43 patients with recurrent C. difficile infection
- Interventions:
- Duodenal infusion of donor feces after a short course of vancomycin and bowel lavage (n=17)
- Standard vancomycin regimen (500 mg orally four times per day for 14 days) (n=13)
- Standard vancomycin regimen with bowel lavage (n=13)
- Duration of follow-up: 10 weeks
- Analysis: Modified intention-to-treat
- Primary outcome: Cure without relapse of C. difficile infection at 10 weeks

Population

Inclusion Criteria

- Age at least 18 years with a life expectancy of at least 3 months
- Relapse of C. difficile infection after at least one course of adequate antibiotic therapy
- Diarrhea and a positive stool test for C. difficile toxin

Exclusion Criteria

- Prolonged compromised immunity (including recent chemotherapy, HIV with low CD4 count, or high-dose corticosteroids)
- Pregnancy
- Use of antibiotics other than for C. difficile treatment at baseline
- Intensive care admission or vasopressor requirement

Baseline Characteristics

- Mean age, sex, comorbidities, and baseline medication use not described in the source text abstract.

Interventions

- Patients either received an abbreviated regimen of vancomycin followed by bowel lavage and donor feces infusion through a nasoduodenal tube, or one of two control treatments consisting of either a standard vancomycin regimen alone or with bowel lavage.

Outcomes

Primary Outcomes

- Donor feces infusion led to cure in 13 of 16 patients (81%) after the first infusion, and an additional 2 were cured after a second infusion from a different donor for an overall 94% cure rate.
- Vancomycin alone cured 4 of 13 patients (31%).
- Vancomycin with bowel lavage cured 3 of 13 patients (23%).
- The difference between the donor feces infusion group and each vancomycin group was statistically significant (P<0.001).

Secondary Outcomes

- Changes in fecal microbiota diversity were observed post-FMT, with an increase towards levels seen in healthy donors.

Funding

This study was funded by the Netherlands Organization for Health Research and Development and the Netherlands Organization for Scientific Research.

Further Reading

The full article can be found at NEJM.org with Supplementary Material accessible at the same source.