Researchers tout pill made of fecal matter to combat deadly infection

The newest tool in the arsenal to stop a deadly infection caused by the use of antibiotics is a pill distilled from fecal matter.

At a conference of infectious disease researchers in San Francisco on Thursday, Dr. Thomas Louie of the University of Calgary presented findings of a trial in which patients were given the custom-made pill incorporating distilled fecal bacteria to stop recurrence of the bacteria Clostridium difficile, also known as C. diff. The bacterial infection can cause diarrhea or destroy the colon. It kills 14,000 people a year in the United States.

Disease from C. diff typically occurs when someone with an underlying disease who has also been infected with the bacteria takes an antibiotic, which wipes out the heathly environment of bacteria in our guts. The C. diff bacteria proceed to fill that void. Younger people with healthy immune systems typically do not develop an illness even if they have been infected, but older patients, immunocompromised patients or patients with other medical conditions are at greater risk.

Last month, the Centers for Disease Control and Prevention released its first report on the state of antibiotic-resistant bacteria, finding that 23,000 people are killed by antibiotic-resistant infections in the United States with another 14,000 killed by C. diff, which is not yet resistant to antibiotics but its spread is linked to their overuse.

Despite what researchers call “the ick factor,” fecal transplants, where donations of stool, typically from a relative of the patient, have emerged as an effective treatment.

But while the thought of getting medication from a relative’s fecal matter may sound unpleasant, “By the time they get to a stool transplant, the patients are so desperate, they will do anything,” said Dr. Ghinwa Dumyati, an infectious disease specialist at the University of Rochester.

Fecal transplants allow the patients to repopulate their guts with similar bacteria to the ones they had before. Dr. Tom Moore, an infectious disease doctor at the University of Kansas who does the transplants through an enema, likened it to re-sodding a lawn after destroying the weeds in order to restore a healthy lawn.

While fecal transplants are successful roughly 90 percent of the time, Louie said all 27 patients in the pill trial recovered from the bouts of diarrhea that characterized their illness. In the course of the trial each patient had to take between 24 and 34 pills, which were made from bacteria isolated from fecal matter donated by relatives of the patient, and then put into a capsule to survive long enough to get through part of the digestive tract and be absorbed. Subsequently, he said, five more patients have taken the pill, with one having a recurrence of the illness.

Dumyati explained that about 30 percent of patients with C. diff have a recurrence, with patients who have a second occurrence having an even higher chance of a recurrence of disease later on. Over time, she said, patients lose weight and may become debilitated and unable to work.

While the pill presents a compelling new way of delivering an effective treatment for C. diff, researchers said it will be dogged by some of the same problems preventing adoption of the pill today.

“A lot of the yuck factor associated with this has to be gotten over by the clinicians first,” said Dr. Ravi Kamepalli, of the Regional Infectious Disease-Infusion Center in Lima, Ohio.

Kamepalli, who started giving patients fecal transplants via an enema and later by a tube inserted through the nose, said much of the challenge is that physicians need to spend time coordinating fecal donation and then preparing the donated stool for transplant.

Another problem with adoption, Moore said, has been concerns by the Food and Drug Administration of use of fecal transplants in an unproven manner, such as to treat depression or autism. For a time earlier this year, this blocked their use for treating C. diff. In Europe, he said, the treatment is used to treat the disease the first time, without waiting for recurrence as in the United States.

As for the pill, which is more complicated to produce, Moore said, “putting it in a capsule is much more palatable, but it’s been my experience that the patients don’t care. They want to get better.” But, he added, “If that’s what it takes to overcome resistance, then by all means we should do it.”