The treatment may sound appalling, but it works.
Transplanting feces from a healthy person into the gut of one who is sick can quickly cure severe intestinal infections caused by a dangerous type of bacteria that antibiotics often cannot control.
A new study finds that such transplants cured 15 of 16 people who had recurring infections with Clostridium difficile bacteria, whereas antibiotics cured only 3 of 13 and 4 of 13 patients in two comparison groups. The treatment appears to work by restoring the gut's normal balance of bacteria, which fight off C. difficile.
The study is the first to compare the transplants with standard antibiotic therapy. The research, conducted in the Netherlands, was published Wednesday in The New England Journal of Medicine.
Fecal transplants have been used sporadically for years as a last resort to fight this stubborn and debilitating infection, which kills 14,000 people a year in the United States. The infection is usually caused by antibiotics, which can predispose people to C. difficile by killing normal gut bacteria. If patients are then exposed to C. difficile, which is common in many hospitals, it can take hold.
The usual treatment involves more antibiotics, but about 20 percent of patients relapse, and many of them suffer repeated attacks, with severe diarrhea, vomiting and fever.
Researchers say that, worldwide, about 500 people with the infection have had fecal transplantation. It involves diluting stool with a liquid, like salt water, and then pumping it into the intestinal tract via an enema, a colonoscope or a tube run through the nose into the stomach or small intestine.
Stool can contain hundreds or even thousands of types of bacteria, and researchers do not yet know which ones have the curative powers. So for now, feces must be used pretty much intact.
Medical journals have reported high success rates and seemingly miraculous cures in patients who have suffered for months. But until now there was room for doubt, because no controlled experiments had compared the outlandish-sounding remedy with other treatments.
The new research is the first to provide the type of evidence that skeptics have demanded, and proponents say they hope the results will help bring fecal transplants into the medical mainstream, because for some patients nothing else works.
"Those of us who do fecal transplant know how effective it is," said Dr. Colleen R. Kelly, a gastroenterologist with the Women's Medicine Collaborative in Providence, R.I., who was not part of the Dutch study. "The tricky part has been convincing everybody else."
She added, "This is an important paper, and hopefully it will encourage people to change their practice patterns and offer this treatment more."
One of Dr. Kelly's patients, Melissa Cabral, 34, of Dighton, Mass., was healthy until she contracted C. difficile in July after taking an antibiotic for dental work. She had profuse diarrhea, uncontrollable vomiting and high fevers that landed her in the hospital. She suffered repeated bouts, lost 12 pounds and missed months of work. Her young children would find her lying on the bathroom floor.
Initially, she rejected a fecal transplant because the idea disgusted her, but ultimately she became so desperate for relief that in November she tried it.
Within a day, her symptoms were gone.
"If I didn't do it, I don't know where I'd be now," she said.
Dr. Lawrence J. Brandt, a professor at the Albert Einstein College of Medicine in New York, said that the Food and Drug Administration had recently begun to regard stool used for transplant as a drug, and to require doctors administering it to apply for permission, something that he said could hinder treatment.
A spokeswoman for the agency, Rita Chappelle, said officials could not respond in time for publication.
C. difficile is a global problem. Increasingly toxic strains have emerged in the past decade. In the United States, more than 300,000 patients in hospitals contract C. difficile each year, and researchers estimate that the total number of cases, in and out of hospitals, may be three million. Treatment costs exceed $1 billion a year.
Fecal therapy has often been used to cure gut trouble in cows and horses. Books on traditional Chinese medicine mention giving it to people by mouth to cure diarrhea in the fourth century; one book called it yellow soup.
In 1958, Dr. Ben Eiseman, of the University of Colorado, published a report about using fecal enemas to cure four patients with life-threatening intestinal infections.
The senior author of the new study, Dr. Josbert Keller, a gastroenterologist at the Hagaziekenhuis hospital in The Hague, said that before conducting the research, he and his colleagues had performed the transplant in about 10 cases, and it almost always worked.
"After the first four or five patients, we started thinking, 'We can't go on doing this kind of obscure treatment without evidence,' " Dr. Keller said. "Everybody is laughing about it."
The researchers studied adults who had been suffering from C. difficile for months and had had at least one relapse after antibiotics. They were picked at random to be in one of three groups. Only one group, 16 people, had the transplant: they took the antibiotic vancomycin for four days, had their intestines rinsed and then had the fecal solution pumped into their small intestines through a nose tube. A second group, 13 people, had the intestinal wash and 14 days of vancomycin; a third group, also 13 people, had only vancomycin.
The donors were tested for an array of diseases to make sure they did not infect the patients. Their specimens were mixed with saline in a blender and strained, to produce a solution that Dr. Keller said resembled chocolate milk.
Dr. Keller said that patients were so eager to receive transplants that they would not join the study unless the researchers promised that those assigned to antibiotics alone would get transplants later if the drugs failed.
Among the 16 who received transplants, 13 were cured after the first infusion. The other three were given repeat infusions from different donors, and two were also cured. In the two groups of patients who did not receive transplants, only 7 of 26 were cured.
Of the patients who did not receive transplants at first and who relapsed after receiving antibiotics only, 18 were subsequently given transplants, and 15 were cured.
The study was originally meant to include more patients, but it had to be cut short because the antibiotic groups were faring so poorly compared with the transplant patients that it was considered unethical to continue.
The results come as no surprise to doctors who have tried the procedure. Dr. Alexander Khoruts, a gastroenterologist at the University of Minnesota, said he had performed the transplants in more than 100 patients with C. difficile. He said that it worked the first time in 90 percent, and that the other 10 percent were cured with a second treatment. The procedure can be done with a stool solution that has been frozen and thawed, he said.
One of Dr. Khoruts's concerns about the procedure is that many people assume it can be used for a variety of intestinal problems. He cautioned that, so far, the only real evidence is for C. difficile.
Eventually, he said, if researchers can determine which bacteria are crucial, it should become possible to create products containing them, and to spare everyone the unpleasantness of dealing with stool specimens.
Post a Comment