A pill containing frozen donated fecal material may be an effective treatment against recurrent Clostridium difficile infection, according to a preliminary study published online by JAMA that also will be presented at IDWeek 2014. In a small study, the pill resolved diarrhea in 90 percent of those who took it.
Ilan Youngster, MD, MMSc, of Massachusetts General Hospital, Boston, and colleagues conducted a study of the pill on 20 patients who had had at least three episodes of mild to moderate C. diff infection and whose conditions had not responded to a 6- to 8-week taper with oral vancomycin or who had had at least two episodes of severe C. diff requiring hospitalization. Study participants received 15 capsules on two consecutive days and were followed up for symptom resolution and adverse events for up to 6 months.
Their research follows studies demonstrating the effectiveness of fecal microbiota transplation (FMT), or a "stool transplant" delivered via the nose to the gastrointestinal system, against relapsing C. diff. The bacterium increasingly is not responding to standard treatments of the oral antibiotics metronidazole or vancomycin, but practical barriers and safety concerns have prevented the widespread use of stool transplants.
In the study by Youngster and colleagues, 70 percent (14) of the 20 patients saw their diarrhea resolve after taking the first round of capsules, and they remained symptom-free after eight weeks. The other 30 percent (six) were re-treated at an average of seven days after the first procedure; diarrhea resolved in four of them. None of the serious adverse events attributed to FMT were observed.
“The use of frozen inocula allows for screening of donors in advance," the authors write. "Furthermore, storage of frozen material allows retesting of donors for possible incubating viral infections prior to administration. The use of capsules obviates the need for invasive procedures for administration, further increasing the safety of FMT by avoiding procedure-associated complications and significantly reducing cost."
Larger studies are needed to confirm the results and evaluate the long-term safety and effectiveness of the pill, they said.
The study is viewable at no cost online