Hold Your Nose, Swallow: Frozen Fecal Pill for Diarrhea

Frozen fecal matter that’s swallowed like a pill appears effective against a recurring and sometimes deadly bacterial infection that can cause devastating diarrhea, a study from Boston researchers found.

A trial of the approach involving 20 people with hard-to-treat C. difficile infections yielded a success rate of 90 percent, with no sign of relapse during the two-month study. Patients took 15 pills on two consecutive days of specially prepared fecal matter that was collected from healthy donors. Fourteen saw immediate improvement, while four others needed a second cycle one week later, the study showed.

The pills may provide an alternative to more difficult ways to conduct fecal transplants, including via colonoscopies, and nasal tubes, said Elizabeth Hohmann, an associate professor of medicine and infectious disease at Harvard Medical School and a senior study author. The approach is part of a new wave of therapy designed to restore normal gut bacteria in people with a wide range of ailments, often caused by antibiotic overuse.

The frozen pills “are all about getting people more comfortable with this as a therapeutic option,” Hohmann said in a telephone interview. “It’s gross but it works really well for these infections that keep coming back.”

The study, released today by the Journal of the American Medical Association, involved patients who ranged in age from 7 to 90. All had suffered at least two episodes of C. difficile infections that were so severe they landed in the hospital or three episodes of milder disease that returned when they started to be weaned from standard antibiotic therapy.

Deadly Infection

The infection leads to 250,000 hospitalizations and 14,000 deaths each year in the U.S. Certain strains of bacteria can easily resist drug therapy, leading to recurrences in 30 percent of patients after a first infection and 60 percent after two or more, the researchers said. Their findings were presented at IDWeek 2014, a meeting of infectious disease specialists.

The researchers didn’t have any trouble recruiting for the trial given the severity of the illness and the team’s earlier success using liquid fecal matter that was delivered through a tube in the nose.

“It’s a pretty easy sell once these folks have had C. diff colitis several times,” said Hohmann, who is also an investigator at Massachusetts General Hospital in Boston. “They were coming to us. I’ve been doing this for two years and I’ve had less than five patients referred to me who said this is so yucky I won’t even consider it.”

The pills make the approach safer since it removes the chance of vomiting up the substance and aspirating it into the lungs, Hohmann said. It’s also easier.

‘Distinctly Unpleasant’

“A colonoscopy or having a tube shoved down your nose is a distinctly unpleasant activity,” she said. “It seemed like we should be able to do this in a way that’s less unpleasant.”

The donors were thoroughly screened. They had to be a healthy weight, have no inflammatory conditions and be taking no medications, including antibiotics for the past six months. Their stool was collected, blended, mixed with medical grade intravenous fluid, put through a sieve and then into capsules.

The capsules were twice coated with a special substance to keep them from dissolving in the stomach, then frozen. The pills are designed to open once they leave the highly acidic stomach. The ultimate hope is for a freeze-dried pill or a super pro-biotic that is made using bacteria grown in a laboratory, Hohmann said.

“Procedures that have been used before -- colonoscopies, nasogastric tubes, even enemas -- all have potential risks and discomforts for patients,” said Ilan Youngster, a fellow in pediatric infectious diseases at Massachusetts General and Boston Children’s Hospital. “The use of capsules simplifies the procedure immensely, potentially making it accessible to a greater population.”

More Patients

The researchers have already treated another 20 patients with similar results. Those who needed a second set of pills were generally sicker and had complicating medical conditions. Many of those who didn’t respond to the first two rounds fared better once higher doses were given, Hohmann said.

There have been rare reports of transmission of infection with the transplants, though none in the study and none that have been conclusively demonstrated.

One of the biggest issues remains getting insurance companies to pay for the treatment.

“There aren’t many things in medicine that are 90 percent effective,” Hohmann said. “It’s distressing to me that I have to argue with insurance companies about paying for this.”

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