The bacteria can take over a person’s intestines and be difficult to eradicate. The infection causes fever, vomiting, cramps and diarrhea so severe that it kills 14,000 people a year in the United States alone.
The first line of treatment for the attacking microbes, called Clostridium difficile, is antibiotics. But a group of Norwegian researchers asked if something more unusual — an enema containing a stew of bacteria from feces of healthy people — might work just as well.
The answer, according to a report today in the New England Journal of Medicine, is yes.
Until now, there has never been a clinical trial conducted in more than one medical center that has investigated so-called fecal transplants as a first therapy for C. difficile infections, said Dr. Michael Bretthauer, a gastroenterologist at the University of Oslo and lead author of the new study.
The Food and Drug Administration permits fecal transplants and professional societies endorse them, but only a last resort for treating C. difficile infections after antibiotics have failed, said Dr. Alexander Khoruts, a gastroenterologist at the University of Minnesota.
“The F.D.A. and all the professional societies are in full agreement on this point,” he said.
Several small clinical trials and doctors’ clinical experience have shown that a fecal transplant can help in that desperate situation.
“It’s definitely a paradigm shift to use it earlier rather than later,” Dr. Nasia Safdar, an infectious disease specialist at the University of Wisconsin — Madison.
The study, conducted in Norway, was small — just 20 patients randomly assigned to get the fecal bacteria or antibiotics. That’s not enough to determine whether transplants are better than antibiotics.
Instead, the research was intended to show that treatment with fecal bacteria is no worse.
Five out of nine patients who received fecal bacteria were cured immediately of their infections, compared to five of 11 in the group getting antibiotics. Three of the four remaining patients who got fecal bacteria then got antibiotics; two were cured within days.
None of the antibiotic patients whose symptoms persisted after their first round of treatment were cured with a second round of the drugs.
Although the results seem to favor treatment with fecal bacteria, the difference was not large enough to say fecal transplants were actually superior to the drugs.
The researchers are planning to start a more definitive study with 200 patients this summer.
The idea behind fecal transplants is to provide a dose of healthy gut bacteria that multiply and crowd out the dangerous germs making patients ill. The bacteria can be extracted from feces and supplied as an enema or in a capsule that patients swallow.
A small company also grows fecal bacteria in a lab and freezes them for transplants. The Norwegian study relied on that company to supply fecal bacteria, but the investigators say the company had no other role in the study.
Researchers are exploring the use of fecal transplants for a variety of conditions, Dr. Bretthauer said, ranging from bowel diseases such as Crohn’s disease and ulcerative colitis “to more far-fetched things, such as multiple sclerosis.”
So far, he added, the most promising evidence for the fecal transplant’s effectiveness is in ulcerative colitis.
One problem with using fecal transplants as a treatment of last resort for C. difficile infections, Dr. Khoruts said, is that it can take a long time for patients to overcome their aversion. On average, he said, these patients struggle through ten months of futile antibiotic treatments before they try a fecal transplant.
Still, some patients newly diagnosed with C. difficile ask Dr. Khoruts why can’t they just get a fecal transplant right away. Their reasoning makes sense, he added. Antibiotics that destroy the normal bacteria that protect against C. difficile are the main reason patients developed the infection in the first place.
Transplants, Dr. Khoruts said, “are trying to repair what was broken in the first place, rather than perpetuate the damage.”
But when Dr. Bretthauer and his colleagues proposed a study testing fecal transplants compared to antibiotics in newly diagnosed patients, other doctors were not enthusiastic.
“Using feces is a little taboo,” Dr. Bretthauer said. “If you are putting someone else’s feces into a patient, there has to be a good reason.”
And, he said, antibiotics are an approved treatment. Doctors are familiar with the drugs. The ethics board that had to approve the clinical trial suggested a small pilot study instead.
The trial was difficult to set up. The challenge was to get to patients before they were given antibiotics.
“We made friends with the hospital lab which did the C. difficile fecal testing,” Dr. Bretthauer said. The laboratory technicians agreed to alert the researchers to new C. difficile cases.
The researchers then rushed to the doctors and asked them to delay giving antibiotics until the patients were asked to enter the study.
The results of the study, Dr. Bretthauer said, “speak for themselves.” But not until a larger trial is completed will he have convincing results that could change clinical practice.
Dr. Khoruts said that in he will wait for the large clinical trial before using fecal transplants as a first-line therapy against C. difficile.
But “if you asked me what if my mother had it?” Then, he said, “I wouldn’t wait” to offer her a fecal transplant.