A BIZARRE TREATMENT FOR CL. DIFFICILE

SAN FRANCISCO — It is not the most appetizing prospect, but pills containing a concentrate of fecal bacteria can stop recurrent Clostridium difficile infections by rebalancing the bacteria in the gut, a new study shows.

The treatment is a potential advance over conventional fecal transplants, which are done with an enema or nasal tube, said lead investigator Thomas Louie, MD, a professor of infectious diseases and microbiology at the University of Calgary in Alberta, Canada.

"A bright light dawned on me," Dr. Louie said. "I would turn it into pills." He presented the study here at IDWeek 2013.

C difficile sickens half a million Americans and kills more than 14,000 every year, said Tom Moore, MD, professor of medicine at the University of Kansas School of Medicine in Wichita, who moderated a news conference about the new treatment.

Fecal transplants from healthy donors have recently emerged as one effective means of stopping infections. Previous research has shown this approach ends C difficile infections in about 9 out of 10 attempts.

"Fecal transplant has been demonstrated to be safe in over 700 published cases," said Dr. Moore. "It's certainly the most effective and efficient way of eradicating C diff."

Typically, patients receive the transplants by enema, colonoscopy, or a nose tube.

As a potentially less costly and less invasive alternative, the Calgary researchers processed feces in a centrifuge, decanting the supernatant layer until it contained only bacteria, then encapsulated it in 3 layers of gelatin. In this way, the pills were unlikely to leak until they reached the small intestine. The researchers made each pill individually.

The recipients took vancomycin prior to taking the pills, but stopped the antibiotic on the day before taking the capsules. On the day they took the pills, they underwent colonic cleansing with sodium picosulfate.

After the patients ingested the capsules, the researchers found significantly increased numbers of Bacteroides, C coccoides, C leptum,Prevotella, Bifidobacteria, and Desulfovibrio and significantly decreased numbers of Enterobacteriaceae and Veillonella. They found no C difficile in the intestines.

Dr. Louie said that he first created a fecal transplant pill when a C difficile infection persisted in one patient who could not tolerate a nasal tube.

In a trial of the pills, 27 patients ingested between 24 and 34 capsules each. Often the feces were donated by family members. All 27 patients recovered from their infections, and none had a recurrence, even though all had at least 4 previous bouts of infection.

Dr. Louie said that he has since treated an additional 5 patients, and 1 of them has had an apparent recurrence of C difficile infection.

In a separate study, also reported here, researchers from the Regional Infectious Disease–Infusion Center in Lima, Ohio, surveyed 28 patients 3 months after undergoing fecal transplants through a nasal tube.

Patients Satisfied

On a scale of 1 to 10, with 10 being total satisfaction, the patients rated the treatment 9.6 overall, 9.9 for ease, and 9.9 for likelihood of recommending the procedure to a family member or friend.

Ravi Kamepalli, MD, an infectious diseases physician at the Regional Infectious Disease–Infusion Center and lead author of the satisfaction study, called on the US Food and Drug Administration to ease its restrictions on the approach.

Currently, it is approved only for recurrent C difficile infections, but Dr. Kamepalli said he had success using it for patients with the acute form of the disease under a research protocol.

"I'm worried about the acute patients," Dr. Kamepalli told Medscape Medical News. "By the time they are recurrent, they are dead."

Another obstacle to wider use of the procedure is the repugnance on the part of physicians, said Dr. Kamepalli. "I'm a small-town physician, and I get patients all the way from Michigan and Cleveland and you name it," said Dr. Kampepalli. "But it's a simple process."

Dr. Moore agreed. "In my experience, it's the yuck factor that has to be overcome, and it's the physicians, not the patients," said Dr. Moore. "The patients want to do it because they've read about it on the Internet."

Dr. Kamepalli, Dr. Louie, and Dr. Moore have not disclosed any relevant financial relationships.

IDWeek 2013. Abstract 89. Presented October 3, 2013.