Aug. 28--Desperate from 20 to 30 bouts of diarrhea a day, resulting in dehydration and organ failure, Catherine Duff pinned her hopes for survival on a fecal transplant, however weird it seemed to put somebody else's stool into her body.
But her doctors in Indiana refused to do what they said was an experimental procedure, even though there was ample evidence from around the globe that such transplants consistently overcome the vicious and stubborn Clostridium difficile infection, typically acquired in hospitals and long-term-care facilities where patients have weakened immune systems. Duff, suffering from recurrent C. diff that wouldn't respond to antibiotics, then asked her husband to do the unorthodox: give her an enema of his processed stool at home.
"I was in a living hell. I was not only thinking I was going to die but wishing I would," Duff said. "I felt I had nothing to lose.
"My husband is a retired submarine commander who was used to being submerged for months with a bunch of men, so not much grosses him out.
"I wouldn't have believed I'd go from deathly ill to being well in just a few hours ... but I felt good enough to shower, go downstairs and eat something, things I hadn't done in months," she said.
That was three years ago. And because her fecal microbiota transplant (FMT) succeeded, Duff is determined to make it easier for others seeking the procedure. She started the Carmel, Ind.-based Fecal Transplant Foundation, a nonprofit that educates and maintains a steadily growing database of physicians who perform FMTs.
About the same time, a microbiologist trained at the Massachusetts Institute of Technology and a business executive were concluding that the increasing number of C. diff infections and the reluctance of physicians to embrace FMTs were creating a major public health failure. They took on a big challenge: providing extensively screened donor stool samples that meet federal Food and Drug Administration regulations. Plus, they devised a way to freeze and deliver the material when needed. Their not-for-profit stool bank, OpenBiome, now works with more than 300 hospitals.
"FMTs needed to be available in a safe and controlled environment," said OpenBiome co-founder James Burgess. His partner, scientist Mark Smith, is research director. "Part of the reason they weren't available before is there's not a lot of money to be made on selling poop."
OpenBiome, based in Medford, Mass., provides stool samples for about $600, including shipping. It has developed a capsule form of FMT that will be available in the fall, ending the need for fecal material to be processed into a liquid for injecting through an enema, colonoscopy or nasogastric tube. Other research is looking at how the microbiome (the complex community of bacteria, fungi, viruses and cells in the human body) can help patients with intestinal disorders, autoimmune diseases and even obesity and depression.
"There's so much we've learned about the microbiome and how it regulates health, but there's a lot we don't understand," Burgess said.
C. diff is a bacterium found in human feces of about 10 percent of the population. Carriers may show no ill effects but can spread infection if they don't wash their hands before touching food and surfaces. Resilient spores can survive for months, some even after being doused with bleach.
The American Gastroenterological Association estimates that 500,000 people a year in the U.S. are infected with C. diff, an opportunistic infection attacking patients taking antibiotics, which can upset the balance of normal bacteria in the gut. The standard treatment is more antibiotics. When the drugs don't work, largely due to their overuse, unrelenting diarrhea can result and lead to dehydration, which may cause dangerously low blood pressure and damage to the kidneys. More than two-thirds of patients require hospitalization. The AGA estimates C. diff causes as many as 30,000 deaths a year. An FMT reintroduces healthy bacteria.
Gastroenterologist Darren Kastin, medical director of the endoscopy department at Edward Hospital in Naperville, Ill., had become frustrated at his inability to help some C. diff patients. He seized upon OpenBiome's stool bank and spent more than a year establishing an FMT program at Edward. He has done about nine fecal transplants since October.
"I saw no reason why it wouldn't work. It's an important procedure to be able to offer patients," Kastin said.
Eleanor Cain, 69, was one of his patients. C. diff acquired during a hospitalization kept her tethered to her toilet, afraid to go out and hesitant for family members to visit, she said. She underwent an FMT via colonoscopy in December, after being told there is scant knowledge on possible long-term consequences. The FDA requires physicians to mention that.
"I was willing to try anything," Cain said. After the FMT, "I've not had one symptom. It's miraculous, really."
Although FMTs are done more frequently, Duff said availability still is a problem. She knows of patients who've been told they can't get a procedure for seven months or longer. She also heard from a patient whose doctor asked for $78,000 in cash, when a procedure should cost under $10,000. She has learned that some doctors mistakenly believe they need special permission from the FDA to do FMTs.
"It should be between patients and doctors. (FMTs) are low risk and low cost. People should be able to try," she said.
Kay Manning is a freelance reporter.
