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Donor Feces Cure Recurrent Diarrheal Infection, Study Shows

An infusion of feces through the nose beat the standard antibiotic as a treatment for a recurrent diarrhea-causing infection that kills about 14,000 Americans a year, a study showed.

In a trial among 43 people with recurrent diarrhea caused by a persistent bug called Clostridium difficile, 81 percent of those who received an infusion of feces from a healthy donor after treatment with vancomycin were cured, compared with only 31 percent of those treated with the drug alone, researchers from the University of Amsterdam wrote in an article published yesterday by the New England Journal of Medicine. The study was stopped early because the treatment was clearly working.

The results validate an approach called fecal microbiota transplantation, or FMT, pioneered in 1958 by doctors in Denver, and provides an alternative for the approximately one-in-four patients whose infection isn’t cleared by initial antibiotic treatment. C. difficile is the most common cause of hospital-acquired infectious diarrhea in the U.S. and costs about $1 billion a year to treat, according to the Centers for Disease Control and Prevention.

“Only patients with the most recalcitrant cases of C. difficile infection are likely to undergo FMT, usually out of desperation after multiple treatment approaches have failed,” Ciaran Kelly, a professor of medicine at Harvard Medical School, wrote in an editorial accompanying the study. The use of feces may be eliminated by the use of cultured bacteria that make the recipient resistant to C. difficile, Kelly said.

Restoring Bacteria

The procedure probably works by restoring normal gut bacteria, the researchers, led by Els van Nood, wrote in the study, which was funded by the Netherlands Organization for Health Research and Development and the Netherlands Organization for Scientific Research.

Vancomycin is sold as Vancocin by ViroPharma Inc. Vancocin accounted for $289 million in sales in 2011, more than half of Exton, Pennsylvania-based ViroPharma’s revenue.

A federal judge last week dismissed the company’s lawsuit against the U.S. Food and Drug Administration over generic forms of the antibiotic developed by Akorn Inc. and Watson Pharmaceuticals Inc.

Optimer Pharmaceuticals Inc.’s Dificid, approved for sale in the U.S. in May 2011, was the first drug cleared for the infection in 25 years.

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