Frozen Fecal Material Effective Treatment for C difficile

Larry Hand

April 24, 2014

A medical team treating patients with Clostridium difficile infection (CDI) achieved an overall 90% cure rate using frozen fecal transplant material as a "biologic therapeutic," according to an article published online April 24 in Clinical Infectious Diseases.

Although some healthcare-associated infections may be on the decline, CDI incidence remains at a high level and is linked with 14,000 American deaths a year, according to the Centers for Disease Control and Prevention.

Recently, researchers have used fecal transplantation to treat the disease, with good results, and have evidence that it is cost-effective. Although one team has tested the use of fecal material in pill form, increasing availability of the treatment remains an issue.

Therefore, Ilan Youngster, MD, from the Division of Infectious Diseases, Massachusetts General Hospital and Harvard Medical School, Boston, and colleagues conducted a pilot study testing frozen fecal material.

They enrolled 20 patients aged 7 to 90 years with relapsing/refractory CDI. Unrelated, normal-weight healthy donors aged 18 to 50 years provided the stools, which the researchers processed to remove particulate material and then froze in inoculum sieves at −80°C for 29 to 156 days.

Researchers administered the inocula through either a colonoscopy or nasogastric tube, with patients divided equally (10 in each study group).

Of the 20 patients, 14 achieved complete resolution of diarrhea after a single administration of fecal microbiota transplantation (8 patients in the colonoscopy group and 6 in the nasogastric tube group). Four of 5 patients who were retreated from same-donor feces achieved a cure, for an overall cure rate of 90% (80% in the nasogastric tube group and 100% in the colonoscopy group). One patient refused retreatment.

No patients relapsed within 8 weeks of follow-up, and no serious adverse events occurred.

In follow-up, the researchers learned that the patient who refused to be re-treated actually self-administered homemade fecal enemas daily for a week, using unprocessed fecal material from his roommate. He told researchers he felt well and was asymptomatic, but according to protocol, he had to be considered as a treatment failure.

"This example also brings to light the potential hurdles associated with regulating a readily available 'biologic therapeutic,' as can also be evidenced by numerous 'how to' manuals published on the Internet," the researchers write.

Among the strengths of this study are the inclusion of 3 children in the study population because of recent increases in pediatric CDI cases, the use of frozen inocula, and the successful administration by nasogastric tube, the researchers write.

Using frozen inocula addresses many obstacles previously encountered "by allowing identification and screening of donors ahead of time and establishing a bank of preprocessed and vetted material that is readily available on short notice," the researchers write.

"Of particular importance is the fact that delivery of the inoculum through the upper gastrointestinal tract seems to be comparable to that of colonoscopic delivery, thus eliminating the need for sedation, anesthetic risks, and colonic 'cleanout,' " they write.

More Widely Available Treatment Now?

Using a frozen preparation "should, hopefully, make it easier for you to bring this to a lot of patients," Vincent Young, MD, PhD, from the Department of Microbiology and Immunology at the University of Michigan, Ann Arbor, told Medscape Medical News. Dr. Young, who was not involved in the study, coauthored a recent review on fecal transplantation.

"The 2 key things are that the frozen works very well, and it didn't matter if you gave it from above or below," he said. This study, combined with previous research, has established the effectiveness of fecal transplant treatment, he said.

"I think there's really no more debate that fecal transplantation is a viable and really effective treatment for recurrent C difficile. One [question] is, is there a way to make it easier? And that's what they show here. You don't actually have to use it fresh. It could be a commercial product you buy frozen. I think that's something that this [study] points to the viability of being able to do."

This research was supported by the National Institute of Allergy and Infectious Disease, the Harvard Catalyst, the Harvard Clinical and Translational Science Center, and Harvard University and affiliated centers. One coauthor has reported being on the board of directors of OpenBiome, a nonprofit organizations for expanding access to fecal microbiota preparations. Another coauthor has reported receiving through Massachusetts General Hospital a sponsored research award from Seres Health for a clinical trial related to C difficile treatment. The other authors and Dr. Young have disclosed no relevant financial relationships.

Clin Infect Dis. Published online April 24, 2014. Abstract

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