[ed. Talk about a "no-brainer". If pharmaceutical companies ever figure out how to get into the action, approval might occur quite a bit sooner. See also: this Washington Post story.]
This pill goes down easier if you forget what is in it.
Inside the experimental capsule is human feces — strained, centrifuged and frozen. Taking them for just two days 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.) (...)
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.
This pill goes down easier if you forget what is in it.
Inside the experimental capsule is human feces — strained, centrifuged and frozen. Taking them for just two days 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.) (...)
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.
by Pam Belluck, NY Times | Read more:
Image: Hohmann Lab