Fecal transplants just got easier to swallow. The procedure, in which the bacteria from a healthy gut are implanted into an unhealthy one, has gotten a lot of buzz over the past year. But the treatment generally requires a colonoscopy — a procedure that's both uncomfortable and expensive.
In a study published Saturday in the Journal of the American Medical Association, researchers report that the same success rate can be reached by processing the healthy excrement into capsules and administering the pills by mouth.
As it stands, fecal transplants are no walk in the park. But for those infected with the bacteria Clostridium difficile, the procedure can be a life-saver. The infection causes 250,000 hospitalizations and 14,000 deaths in the U.S. each year, and up to 30 percent of patients don't respond to antibiotics. The chronically infected can suffer from debilitating digestive issues.
Doctors have had great success with fecal microbiota transplantation, or FMT. A healthy donor provides a stool sample, which is introduced to the patient by way of either a colonoscopy or a tube snaking down from the nose to the stomach. That fecal matter carries the bacterial colonies that help maintain the donor's healthy gut. The transplanted bacteria can often fight off C. difficile within days.
In a previous study by the same group, frozen donor samples were found to be as effective as fresh — meaning that donors can be recruited and collected from at any time, instead of right when a donation is needed.
But most insurance companies don't cover the cost of surgical delivery — and it can cost about $3,000 out of pocket. Led by Elizabeth Hohmann of the Massachusetts General Hospital Infectious Diseases Division, the new study aimed to make the treatment as simple and inexpensive as possible.
The process starts the same way as usual, Hohmann said: "Sort of gross, but pretty simple." Exceptionally healthy young people — those that pass all requirements for blood donation, as well as being screened for other health factors — provide stool samples, which are then blended with medical-grade saline and filtered.
But instead of that uniform liquid being pumped into a patient, it's concentrated into a single capsule. Another layer of capsule goes on top, and the whole thing is kept frozen. A single treatment requires a gulp-worthy 30 pills — 15 on the first day and 15 on the second. But don't knock it: In a trial of 20 patients, it brought normal bowel health and function to 18 — which is the same rate of success seen in more invasive methods.
Plus it's cheaper. Hohmann estimates that the entire course would cost $500 — one sixth the price of either a colonoscopy or a standard course of antibiotics.
Colleen Kelly, an assistant professor at Brown Alpert Medical School who wasn't involved in the study, thought that the results were promising, though larger studies would need to be done to confirm the findings. Kelly has provided FMT via colonoscopy for the past six years, but has only treated 200 patients.
"Encapsulated formulations would enable many more patients to be treated more efficiently," Kelly said. "There might even be greater safety, since these capsules could be held for a period of time and discarded if donors showed any signs of illness."
Hohmann has treated another 21 patients since the trial, with continued success. But are they happier about swallowing fecal matter than they are about having a colonoscopy?
Not always. "Bizarrely, there are people who say, 'Gee, I'd much rather have this by colonoscopy,' " Hohmann said. But once they see the difference in cost, they usually change their minds. "I think for most people it's going to be easier to deal with the capsules [than a colonoscopy]," she said, "because we're a pill-based society. We're really big on pills here in the U.S., so it's easier to get over mentally."
For those suffering terribly from a persistent C. difficile infection, any method of FMT is a good one. And for now, the FDA only allows FMT in the treatment of that specific illness.
But several companies are working on commercializing encapsulated fecal donations (or trying to create cocktails of bacteria that have the same effect on a patient's gut), and they're banking on wider uses eventually coming to light — and getting FDA approval. "The human microbiome is just an exploding area of science," Hohmann said, "and we're still figuring out what we might do with these communities of bacteria."
Other diseases of the gut like inflammatory bowel syndrome and Crohn's disease are next at bat. But theoretically, FMT could even be used to treat obesity.
Some patients suffering from problems other than C. difficile infection (or in sticker-shock over the price of a colonoscopy) try to make their own treatments at home. That's not the best idea. They have no way of knowing that the donation they use is actually healthy, Hohmann said, and could be exposing themselves to dangerous infection.
Even in a doctor's office, the treatment isn't necessarily for everyone. Hohmann stressed that the therapy, while highly effective, is in its early stages. "It's a really easy decision to make on a 75-year-old person who's home-bound by diarrhea they can't get rid of," she said, "but it's another thing to talk about giving the treatment to a toddler. We have a lot to learn — and hopefully, it's all positive."