Fecal Transplants Increasingly Seen as Legitimate Treatment

Clostridium difficile, or C. diff, can be a stubborn and even life-threatening infection. But, increasingly, gastroenterologists are turning to a plentiful, natural and relatively inexpensive remedy to cure it.

Feces.

Studies show that fecal transplants are highly effective against recurrent C. diff infections. The Food and Drug Administration, which regards the transplants as a drug, still considers them to be experimental. But in 2013 it published a guidance document that said it would allow doctors to use the treatment outside of clinical trials in C. diff patients for whom other conventional treatments haven’t worked.

C. diff is a bacterium that causes inflammation of the large intestine, or colon, resulting in watery diarrhea, fever, loss of appetite, nausea and abdominal pain. The infection typically strikes people who have been in a health care setting, such as a hospital or nursing home. Its victims have been on prolonged treatment with antibiotics, which wipe out the good, protective bacteria in the gut as well as the bad bugs, giving C. diff room to grow. Treatment typically consists of stronger antibiotics.

Older people are especially at risk. C. diff is found in feces, so it can be spread when people touch a contaminated surface and then touch their mouth, nose or eyes.

In 2011, almost half a million C. diff infections occurred in the United States, and 29,000 people died within 30 days of the initial diagnosis, according to the Centers for Disease Control and Prevention.

But fecal transplants can make a difference. A clinical trial published in November in the Annals of Internal Medicine randomly assigned 46 patients to transplants of either donor stool or their own stool. Of the 22 who received donor stool, 20, or 91 percent, were cured, compared to 15 of the 24, or 62.5 percent, who received their own stool. All nine patients who developed a recurrent C. diff infection after getting their own stool subsequently received a transplant of donor stool, which cured them. The transplants are thought to work by replenishing the recipients' guts with good bacteria that crowd out the C. diff.

Researchers are also testing the treatment in patients with a number of other conditions, including irritable bowel syndrome, Crohn’s disease and ulcerative colitis. Instead of enrolling in a clinical trial, though, some patients with digestive tract problems other than C. diff are performing do-it-yourself fecal transplants at home via enemas.

You might find the thought of a fecal transplant less than appetizing, but, says Dr. Lawrence Brandt, a pioneer in the treatment and coauthor of the Annals study, “I have really never had a patient who said, ‘Oh, that’s disgusting.’ These are patients who’ve essentially sought us out.” Brandt, a professor of medicine and surgery at Albert Einstein College of Medicine in New York, says he has performed more than 450 fecal transplants at Montefiore Medical Center over the last 16 years.

Cleveland Clinic gastroenterologist Bret Lashner, who says he has performed about 80 fecal transplants to treat C. diff over the last couple of years, echoed Brandt. “I have lots of happy patients,” Lashner said. “They are grateful we do this for them.”

There's even a nonprofit stool bank in Boston called OpenBiome that collects and stores the stuff from donors who've screened for a variety of infectious diseases. Since OpenBiome sent out its first treatment in October 2013, it has provided more than 16,000 treatments to physicians at more than 700 medical centers located in every state and six other countries, according to its website. Donor stool is usually transplanted into patients via a colonoscopy or, sometimes, a tube inserted into the nose and passed into the stomach, but OpenBiome also makes capsules that can be swallowed.

Virtually the entire U.S. population, 96.7 percent, to be exact, lives within a two-hour drive of a hospital or clinic that offers fecal transplants, according to data presented at scientific meetings in November by OpenBiome.

Brandt estimated that perhaps one in 10 gastroenterologists perform fecal transplants. “There are still gastroenterologists who think it’s quackery,” he acknowledged.

Brandt said he performs one to three transplants a week. C. diff patients often have already had multiple colonoscopies, he said, and he tells them the transplant “will be no different from any other colonoscopy that they’ve had,” although they might feel a little more gassy and crampy. The infection usually clears up within three to five days of the transplant, and if it hasn’t recurred within eight weeks, they’re considered cured, Brandt said.

He uses donor stool from OpenBiome, which, he said, charges $375, including shipping, for each treatment. “I no longer have the patient get a donor because, frankly, it was a very involved process,” Brandt said. Prospective donors had to be tested for parasites, HIV, syphilis and other infectious diseases, and then Brandt collected the donor’s stool and prepared it for the transplant. “It took me a lot of time. It took the donors a lot of time.”

At the Cleveland Clinic, on the other hand, it's still BYOD — bring your own donor. “Typically, patients choose their own donor, because they know them pretty well, they know their habits,” Lashner said. “They’re comfortable with them. They don’t expect them to be positive for any infectious disease.” Even so, he said, “we have found that once I explain what I’m looking for, there are people who refuse donation before testing.”

Of course, Lashner said, it isn’t difficult to find another donor. “I’ve never encountered someone who needed a transplant and couldn’t provide a donor for me.”