Recurrent Clostridium difficile infection is difficult to treat, and failure rates for antibiotic therapy are high. Researches have studied the effect of duodenal infusion of donor feces in patients with recurrent Clostridium difficile infection.
Investigators have randomly assigned patients to receive one of three therapies: an initial Vancomycin regimen ( 500 mg orally four times per day for 4 days ), followed by bowel lavage and subsequent infusion of a solution of donor feces through a nasoduodenal tube; a standard Vancomycin regimen ( 500 mg orally four times per day for 14 days ); or a standard Vancomycin regimen with bowel lavage.
The primary end point was the resolution of diarrhea associated with Clostridium difficile infection without relapse after 10 weeks.
The study was stopped after an interim analysis.
Of 16 patients in the infusion group, 13 ( 81% ) had resolution of Clostridium difficile-associated diarrhea after the first infusion. The 3 remaining patients received a second infusion with feces from a different donor, with resolution in 2 patients.
Resolution of Clostridium difficile infection occurred in 4 of 13 patients ( 31% ) receiving Vancomycin alone and in 3 of 13 patients ( 23% ) receiving Vancomycin with bowel lavage ( P less than 0.001 for both comparisons with the infusion group ).
No significant differences in adverse events among the three study groups were observed except for mild diarrhea and abdominal cramping in the infusion group on the infusion day.
After donor-feces infusion, patients showed increased fecal bacterial diversity, similar to that in healthy donors, with an increase in Bacteroidetes species and Clostridium clusters IV and XIVa and a decrease in Proteobacteria species.
In conclusion, the infusion of donor feces was significantly more effective for the treatment of recurrent Clostridium difficile infection than the use of Vancomycin. ( Xagena )
van Nood E et al, N Engl J Med 2013; 368:407-415