A Promising Pill, Not So Hard to Swallow
This pill goes down easier if you forget what is in it.
Inside the experimental capsule is human feces — strained, centrifuged and frozen. Taken for just two days, the preparation can cure a dangerous bacterial infection that has defied antibiotics and kills 14,000 Americans each year, researchers said Saturday.
If the results are replicated in larger trials, the pill, developed at Massachusetts General Hospital in Boston, promises an easier, cheaper and most likely safer alternative to an unpleasant procedure highlighted in both medical journals and on YouTube: fecal transplants.
Studies show that transplanting feces in liquid form from healthy people to patients with stubborn Clostridium difficile infections can stop the wrenching intestinal symptoms, apparently by restoring healthy gut bacteria.
But fecal transplants are not easy. The procedure requires delivery of a fecal solution via the rectum or a tube inserted through the nose. As with colonoscopies, patients must flush their bowels first.
Finding and screening donors is time-consuming and can delay the transplant. And the costs can be significant, certainly higher than taking a simple pill.
“Capsules are going to replace the way we’ve been doing this,” said Dr. Colleen Kelly, a gastroenterologist with the Women’s Medicine Collaborative in Providence, R.I., who was not involved in the study. Dr. Kelly performs five or six fecal transplants a month, but demand is so great she is booked through January.
“It’s so labor-intensive,” she said. “You have to find a donor, have to screen a donor. If you can just open a freezer and take out a poop pill, that’s wonderful.”
While the pills are not being marketed yet, the authors of the study, published in JAMA, are already making them available to qualified patients without requiring participation in clinical trials.
Their study was small and preliminary, but results were striking: 19 of 20 patients with C. difficile infections were cured of diarrhea and related symptoms. Most saw improvements after one two-day round of pills, the rest after two or three rounds, said Dr. Ilan Youngster, the lead investigator.
Other research teams, and at least one private company, are developing and testing fecal pills. Currently, the Food and Drug Administration effectively permits doctors to give fecal transplants to qualified patients with recurrent C. difficile infections. Pills marketed commercially would have to meet F.D.A. drug-licensing regulations.
Dr. Lawrence Brandt, an emeritus chief of gastroenterology at Montefiore Medical Center who was not involved in the study, noted that “capsules are easy to take and do not have any kind of offensive odor.” Some experts said they also hoped that pills would discourage people from potentially dangerous do-it-yourself fecal transplants, which have been featured in YouTube videos.
People have used stool from family or friends, often administering it via enema.
“I know of at least one person who did it at home and came in with a very severe infection in his bowel,” said Dr. Youngster, a pediatric infectious disease physician at Massachusetts General.
That patient, treated by a colleague, “did a home brew of stool from a 2-year-old infant.”
In their study, Dr. Youngster and colleagues recruited donors via Craigslist and screened their stool to make sure it was healthy.
The stool was mixed with saline and put through sieves to remove “the yucky stuff,” Dr. Youngster said, then centrifuged and mixed with glycerol to keep bacteria alive when frozen. It was piped into capsules, which were stored in deep-freeze and transferred to a regular freezer before patients swallowed them.
Dr. Youngster said the capsules could be stored for 250 days or longer. The capsules are clear, so “the fact that they are frozen is actually good, because then you can’t see what’s in them.”
The patients, 11 to 89 years old, had each experienced at least two episodes of C. difficile that antibiotics had failed to control. After one round of dosing (two days, 15 capsules per day), diarrhea cleared up in 14 patients. Five others, sicker than the rest beforehand, responded after a second two-day dosing about a week later. One of this group relapsed and needed another dose.
One patient may not have responded because of liver problems, Dr. Youngster said. There were no serious side effects, not even the vomiting researchers had expected. Six patients had mild cramps or bloating.
Deirdre, 37, a technology consultant in Boston, acquired C. difficile after receiving antibiotics for a breast infection and struggled with recurrences for months before learning of the study.
“At first I was kind of grossed out,” said Deirdre, who asked that her last name be withheld because of privacy concerns. But about a week after taking the capsules, which “kind of felt like small ice cubes,” her digestive system began to normalize.
“If this is a treatment that was 90 percent effective and you can get over the gross factor, it seems to be kind of a no-brainer,” she said.
Interest in fecal treatments has grown since a 2013 study found transplants are nearly twice as effective as antibiotics for recurring C. difficile. A nonprofit in Cambridge, Mass., OpenBiome, sends frozen stool samples to hospitals for fecal transplants.Pills are being tested with promising results elsewhere, and a company called Seres Health is in advanced trials of a pill incorporating certain bacteria from stool.
Dr. Alexander Khoruts, a gastroenterologist at the University of Minnesota, said some researchers were trying to freeze-dry stool samples so they could be made into powders that could be stored at room temperature.
Dr. Josbert Keller, a Dutch gastroenterologist who led last year’s fecal transplant study, said he would try capsules. “It’s much easier for the patient,” he said.