Tue April 9, 2013
Charlotte Medical Team Uses 'Ick' Factor To Cure Stubborn GI Infection
Pam Kee calls herself a “mixologist.”
But the concoction in her blender comes together at a hospital.
Kee is a nurse at Carolinas Medical Center-University, where she assists Dr. Barry Schneider with an unusual therapy that can cure a potentially deadly gastrointestinal infection.
The treatment is called a fecal transplant – and it’s just what the name implies.
Feces from a healthy donor is transferred into a sick patient to create a new, infection-free environment in the gut.
It may sound disgusting, but it works.
The New England Journal of Medicine recently reported on a study in the Netherlands that found fecal transplants significantly more effective than standard antibiotics to treat the persistent infection called Clostridium difficile, or C. diff, for short.
“This is a procedure that is saving lives,” said Dr. Lawrence Brandt, a gastroenterologist at Albert Einstein College of Medicine in New York.
Brandt, who was not involved in the Dutch study, has been performing fecal transplants for 14 years.
“The only people who say it’s disgusting are sometimes the doctors,” Brandt said, “and even doctors are coming around now.”
Last summer, Schneider performed the first fecal transplant in Charlotte. He’s one of a handful of North Carolina doctors who have embraced the strange-sounding treatment.
Brandt estimates that fewer than 100 doctors in the country offer it now. But that’s about to change, as he and others pursue research they hope will bring the therapy into the medical mainstream.
Interest is high because of the dramatic rise of C. diff infection in the United States. An estimated 3 million cases occur each year in hospitals and nursing homes. The infection is linked to 14,000 deaths each year.
Patients often develop the infection after taking antibiotics that wipe out beneficial, as well as harmful, bacteria in the gut, and also after surgery, when immune systems are weak. The infection is hard to treat because the bug has become resistant to antibiotics.
Today, fecal transplants are typically considered as a last resort, after antibiotics have failed to cure recurrent infections. But that could change if research proves what doctors have reported anecdotally. Even before the Dutch study, Brandt published a report on 77 patients who had fecal transplants at five different centers. Ninety-one percent were cured after only one transplant; 98 percent after the others got a second.
The treatment appears to work because healthy bacteria in the donor’s feces repopulate the sick patient’s gut, restoring balance and preventing C. diff germs from causing disease.
“I think we’re on to something here,” Schneider said.
New approach to problem
As medicine becomes more high-tech – from gene therapy to robotic surgery – these transplants stand in contrast. They’re about as low-tech as you can get, using the body’s natural byproduct.
At 59, Schneider finds it rewarding to be trying something new that works so well for such a stubborn infection. In 25 years as a gastroenterologist, he has twice gone to the extreme of removing the colons of C. diff patients who didn’t respond to antibiotics.
He first considered a fecal transplant after meeting a particularly desperate patient.
The Gaston County woman, in her 80s, had developed the infection last year after surgery and had taken four courses of antibiotics without success. The stronger the antibiotic, the more expensive: One 10-day course of Dificid, a new drug, cost $3,000.
The woman’s distraught family had, like Schneider, read about fecal transplants, and encouraged him to try it.
After getting approval from a hospital committee, Schneider did the transplant in August. The patient, who had been house-bound for six months because of diarrhea, got well in a couple of days.
Since then, Schneider – with nurse Kee’s help – has performed five more transplants at CMC-University. Two doctors at CMC-Pineville have performed four, including two on one patient. All the patients have been cured.
‘A big “ick” factor’
Before Kee prepares a donation, she dons two surgical masks that she has sprayed with a “Rain Fresh” fragrance from an aerosol can.
“Two things you need in this job,” she said. “A sense of humor and good air freshener.”
Properly masked, gowned and gloved, Kee drops a scoop of the sample into a cheap Hamilton Beach blender and mixes it with salt water to produce what she calls “liquid gold.”
Each blender gets used only once.
When the mixture reaches the right consistency, she pours it through a gauze filter, and then fills more than a half dozen huge syringes. These go to Schneider, who uses them to transfer the healthy material into a sedated patient as part of a colonoscopy.
“There’s a big ‘ick’ factor” to the job, Kee said. She lost a few assistants who couldn’t stand the smell. But Kee embraces her reputation as “the Princess of Poop” and keeps her focus on the patients.
“You’re helping people,” she said.
Screening process is key
These transplants are not new. Veterinarians have long used them to treat gut trouble in cows and horses. And the Chinese used fecal therapy for humans as far back as the fourth century.
But the New England Journal report, published in January, was the first to compare fecal transplants to antibiotics. Of 16 C. diff patients who received the transplants, 13 were cured after one infusion; two more after a second.
The results were no surprise to Dr. Colleen Kelly, a gastroenterologist at Brown University, who has used fecal transplants since 2007, treating 98 patients and curing 95 percent.
Kelly and Brandt are heading the first U.S. randomized, controlled clinical trial. Of 48 patients, half will get transplants from donors, half will get their own feces (with C. diff).
Kelly pushed for a study so the therapy can be approved by the FDA, standardized for use in all patients and monitored for adverse outcomes. Only with monitoring can doctors detect serious side effects, Kelly said.
For now, she said, it’s almost unethical not to offer the transplant because it has worked so well in so many patients and with few side effects.
“By the time they come to me, they’re so desperate they would do anything,” she said.
Some people have even been known to try the procedure at home, by mixing up a donor sample and infusing it like an enema.
One important consideration, Kelly said, is proper screening of donors for HIV, hepatitis and other infectious diseases that could be spread to transplant recipients. The best donors are healthy people who haven’t taken antibiotics for at least 90 days. Most patients choose family members, but donors don’t have to be relatives.
Already, some doctors use frozen, instead of fresh, samples that are thawed before transplantation. Brandt predicts a day when all the right organisms will be identified and produced in capsule form.
“Nobody’s going to be using stool in five years,” he said.
A cure for misery
In Charlotte, Schneider’s fourth patient was Jan Bleavins, a grandmother of nine who had her transplant Dec. 3.
Over the years, Bleavins has survived colon cancer, breast cancer and shoulder replacement surgery. But her struggle with C. diff was “right up there,” she said. “This wiped out pretty much six months of my life.”
Last June, after several days of extreme diarrhea, Bleavins ended up in the emergency room.
“My son actually carried me to the car. I was so weak,” she said.
She took intravenous antibiotics but didn’t get better. In the next two months, she was back in the ER twice and took two different oral antibiotics. The final prescription, a four-week dose of vancomycin, cost $6,000. She paid $4,000 out of pocket, and insurance paid the rest.
But she still wasn’t better. That’s when she was referred to Schneider, who suggested the transplant.
“That sounds different,” Bleavins thought. But after reading more on the Internet, she agreed to do it. Her daughter came with her to the hospital to be her donor.
Bleavins had the transplant on a Tuesday, and “by the weekend, I was great,” she said. “I had my energy back.”
She wishes she’d known about the procedure earlier, to save a lot of time and expense. That’s why she agreed to speak publicly about what many would consider an embarrassing experience.
“It’s rather personal, you know, but I’m just interested in passing the word,” she said. “If it would help to stamp this out sooner, that would be great.”
Go to the Charlotte Observer.