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Trial bolsters fecal infusion efficacy against C. difficile

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A stimulus for greater use

This trial addresses one of the main impediments to the routine use of fecal microbiota transplantation (FMT) since it was first performed in 1958: a lack of efficacy data from randomized controlled trials. The results support an earlier systematic review of uncontrolled case series in which the overall response rates of FMT were 80% through the stomach or small intestine and 92% through colonoscopy or enema.


Dr. Ciaran P. Kelly

Despite the resurgence of FMT in recent years as a result of the past decade’s increase in the incidence and severity of C. difficile–associated diarrhea, it has not become mainstream, and only the most recalcitrant cases are likely to undergo it, "usually out of desperation after multiple treatment approaches have failed."

The trial’s findings "will provide added stimulus to the ongoing efforts to address the other main impediments to the routine and widespread use of FMT": unappealing aesthetics and the logistical challenge of harvesting and processing donor material.

Ciarán P. Kelly, M.D., is a professor of medicine in the division of gastroenterology at Beth Israel Deaconess Medical Center and Harvard Medical School, both in Boston. He reported having financial ties to many companies developing therapies for treating C. difficile infection. These comments are taken from his editorial accompanying Dr. van Nood’s report (N. Engl. J. Med. 2013 Jan. 16 [doi: 10.1056/NEJMe1214816]).


 

FROM THE NEW ENGLAND JOURNAL OF MEDICINE

Eighteen patients from the two control groups who relapsed after antibiotic treatment switched to off-protocol infusions of donor feces. Fifteen of them (83%) were cured: 11 after a single fecal infusion and 4 after two infusions.

All but one of the patients who received fecal infusions experienced immediate diarrhea, sometimes with cramping (31%) and belching (19%). These symptoms resolved in all of them within 3 hours. The only other adverse event that may have been related to the treatment was constipation, which developed in three patients.

Although the exact mechanism of action of this "unconventional" therapy is not yet known, Dr. van Nood and her colleagues speculated that donor-feces infusion probably restores the normal intestinal microbiota, enhancing the host defense against C. difficile.

Future research must determine the optimal protocol for donor-feces infusion, including the amount of feces required. Alternative routes of infusion, such as via enema or colonoscopy, also should be explored, they added.

This study was supported by the Netherlands Organization for Health Research and Development and the Netherlands Organization for Scientific Research. Four of the study’s 13 authors reported ties to Astellas. Two of those four also reported ties to Microbex.

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