Clostridium difficile Colitis

Can Frozen Fecal Material Treat Diarrhea?

Treating Clostridium difficile infection (CDI) with frozen encapsulated fecal material yielded 90% resolution in diarrhea, according to a recent study.

CDI is a major cause for death and illness globally.  While it is currently remedied through invasive procedures to perform fecal microbiota transplantation (FMT)—a transplantation of a healthy person’s stool in order to restore normal gut bacteria through the infected person—the capsulized version of the frozen material developed by researchers eliminated the need for any gastrointestinal procedures, avoiding complications related to those procedures, and lowering costs.
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For the study, researchers examined 20 participants with a minimum of 3 mild-to-moderate CDI episodes and oral vancomycin failure (a 6-to-8 week taper) or a minimum of 2 episodes of major CDI that required hospitalization.

After potential, healthy donors were screened and FMT capsules were produced and frozen, participants were administered 15 capsules (for 2 consecutive days) and received a 6-month follow-up for adverse events and symptom resolution.

Of the participants, 14 (70%) yielded clinical diarrhea resolution after the initial capsule administration, and were free of symptoms at 8 weeks. After a mean of 7 days post first capsule treatment, the 6 non-responsive participants were treated again. Of the 6 individuals, 4 achieved diarrhea resolution resulting in a 90% overall rate of clinical resolution.

Further, daily bowel movements minimized from an average of 5 the day before the first procedure to 2 bowel movements on day 3 and 1 bowel movement at 8 weeks.

Investigators noted that no adverse events linked to FMT were reported during the study.

“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,” said IIan Youngster, MD, MMSc, and colleagues, the authors of the study and researchers at the Massachusetts General Hospital in Boston.

The complete study is published in the October issue of the Journal of the American Medical Association.

-Michelle Canales

References:

Youngster I, Russell GH, Pindar C, et al. Oral, capsulized, frozen fecal microbiota, transplantation for relapsing Clostridium difficile infection. JAMA Intern Med. 2014 October [epub ahead of print] doi: 10.1001/jama.2014.13875.

JAMA Network. Study shows feasibility of treating Clostridium difficile infection with oral administration of frozen encapsulated fecal material. October 11, 2014. http://media.jamanetwork.com/news-item/study-shows-feasibility-of-treating-clostridium-difficile-infection-with-oral-administration-of-frozen-encapsulated-fecal-material/. Accessed October 14, 2014