by Bruce Sylvester: Treatment of recurrent Clostridium difficile infection with oral, frozen and encapsulated fecal material from unrelated donors has resulted in a 90 percent rate of resolution of diarrhea, researchers reported on Oct.11, 2014 in the Journal of the American Medical Association/ JAMA.
The study was also presented orally and concurrently at ID (Infectious Diseases) Week 2014.
“Numerous reports have shown that FMT [fecal microbiota transplantation] is effective in treating active C. difficile infection and preventing recurrences in patients whose infections failed to respond to standard treatments,” said investigator Ilan Youngster, MD, a fellow in Pediatric Infectious Diseases at Massachusetts General Hospital and at Boston Children’s Hospital in Boston. “The procedures that have been used before – colonoscopies, nasogastric tubes, even enemas – all have potential risks and discomforts for patients. The use of capsules simplifies the procedure immensely, potentially making it accessible to a greater population.”
As background, the authors noted that recurrent Clostridium difficile infection is a major cause of illness and death, and current treatment with the antibiotics metronidazole or vancomycin is increasingly ineffective.
The researchers created a capsulized delivery system that can be given orally and eliminates gastrointestinal procedures.
The endpoints of the study were safety and rate of diarrhea resolution associated with oral administration of frozen FMT capsules.
The researchers enrolled 20 patients with at least three episodes of mild to moderate CDI and failure of a 6- to 8-week oral vancomycin treatment, or at least 2 episodes of severe CDI requiring hospitalization.
They screened volunteers, identified healthy donors and created and froze the FMT capsules.
The subjects received 15 capsules on 2 consecutive days. They were tracked for up to 6 months.
The investigators reported that 14 out of the 20 subjects achieved clinical resolution of diarrhea after the first administration of capsules (70 percent) and remained symptom free at 8 weeks. The 6 non-responders received another treatment at an average of 7 days following the first procedure. And 4 of them achieved a resolution of diarrhea. This amounted to an overall 90 percent rate of clinical resolution of diarrhea.
Bowel movements decreased from a median of 5 on the day prior to FMT administration to 2 at day 3, and 1 at 8 weeks.
Self-reported health ratings improved significantly over the study period. There were no serious adverse events attributed to FMT.
The authors concluded, “If reproduced in future studies with active controls, these results may help make FMT accessible to a wider population of patients, in addition to potentially making the procedure safer. The use of frozen inocula allows for screening of donors in advance. 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.”