A new study has found that an infusion of feces from a healthy person into an ailing patient's gut was significantly more effective than a traditional antibiotic treatment ? raising hopes that the unconventional approach could one day help combat obesity, food allergies and a host of other maladies.
The study, published online Wednesday by the New England Journal of Medicine, demonstrated that the fecal transplant cleared up a recurrent bacterial infection far more reliably than the routinely prescribed medication. In fact, the transplant was so successful that the research trial was ended early so that patients in the control groups could be given the remedy as well.
As a treatment for recurrent Clostridium difficile infection ? an ailment that affects nearly 1% of patients hospitalized in the U.S. and plays a role in an estimated 100,000 deaths a year ? the transplant had a 94% cure rate, three times greater than for those who took only the antibiotic vancomycin.
"It's a strange concept to use stool, which has always been looked on as something dirty," said Dr. Lawrence Brandt, a gastroenterologist at the Albert Einstein College of Medicine in New York who has conducted transplants for 14 years but wasn't involved in the study. "We're entering a very exciting new chapter in medicine."
Viewed for many years as a fringe medical treatment, fecal transplants are generating new interest among physicians and patients. This is due largely to an explosion in cases of C. difficile infection, or CDI, among elderly patients in nursing homes and hospitals who are getting more difficult to treat because of a proliferation of antibiotic-resistant bacteria.
More broadly, the remedy has captured the attention of doctors and researchers who are trying to capitalize on scientists' more complete understanding of the teeming assortment of microorganisms that live within the body and influence its health. Some suggest that fecal transplants might one day help to combat a host of conditions that stem from problems in the gut, including irritable bowel syndrome and anorexia.
Though the precise mechanism by which the transplant fights disease remains unclear, scientists believe it has to do with restoring microbial diversity to an ailing gut. Feces from a healthy donor contain a rich and complex assortment of organisms that have developed beneficial, symbiotic relationships with humans over millions of years of evolution. These gut bacteria influence our metabolic rate, immune system performance, muscular function and even our mood, Brandt said.
An imbalance in these organisms can carry dire consequences. Patients infected with C. difficile are often seniors who have recently taken antibiotics that killed off beneficial bacteria in their gut, leaving it open to invasion. The bug produces hardy spores that can survive for weeks or months in hostile environments outside the body. If a patient touches a contaminated surface, such as a door knob or remote control, and then touches his mouth before washing his hands, he can ingest the bacterium.
When C. difficile reaches a human gut, it begins to multiply and produces toxins. Patients can develop recurring diarrhea, cramping, nausea and fever that sometimes leads to death. Americans spend more than $3.2 billion a year to treat it, the Caro Research Institute of Concord, Mass., has found.
The new study, conducted in the Netherlands, is the first randomized clinical trial to demonstrate that fecal transplants can work without causing serious adverse effects. It follows more than 300 case reports from Europe and North America that have endorsed the procedure.
"The study is very exciting," said Dr. Colleen Kelly, a gastroenterologist at Brown University's Alpert Medical School in Providence, R.I. Kelly, who was not part of the Dutch research team, is a vocal proponent of fecal transfusions and has performed them for four years. "I hope this will help to change minds. Those of us who do them know they're effective, and to our patients, it's like a miracle."
The study involved 43 CDI patients who were divided into three groups. One group was treated with vancomycin alone; another group got vancomycin plus bowel lavage, or cleansing; and the third group received vancomycin, bowel lavage and a fecal transplant.
The remedy was made by combining freshly excreted stool from a healthy donor with a pint of lightly salted water. After stirring and straining, the concoction was delivered through a nasal tube that snaked down to the first section of the small intestine, bypassing any opportunity for patients to taste or smell the solution. (Transplants can also be introduced rectally with an enema or colonoscope.)
Of the 16 patients in the transplant group, 13 were cured after their first infusion and two of the remaining three were cured following a second treatment. By comparison, only 31% of those in the vancomycin-only group were cured, along with 23% of patients treated with vancomycin plus lavage.
"We of course hoped the treatment would show results like these, but we did not anticipate such a big difference," said Dr. Els van Nood of the University of Amsterdam Department of Internal Medicine, who led the study.
Researchers examined the patients' feces to assess microbial diversity before and after transplantation. The number of organisms living in the patients' stool was greater and more varied as the patients became healthier.
The medicinal use of stool to treat illness dates back to 4th century China, when the physician Ge Hong described fecal solutions for the treatment of food poisoning and severe diarrhea. The remedy was considered a "medical miracle that brought patients back from the brink of death," Dr. Faming Zhang of Nanjing Medical University wrote in the American Journal of Gastroenterology.
Later, in the 16th century Ming Dynasty, herbal healers prescribed fermented fecal solutions for abdominal ailments, calling the concoction "yellow soup" to make it more palatable.
Doctors in the West were more reticent, although it was known that certain mammals, such as dogs and camels, consumed excrement when they were ill, and that veterinarians sometimes used a fecal solution to treat ill horses. It wasn't until 1958 that the first scientific paper on the use of fecal transplants in humans appeared in the United States. Kelly and Brandt, who have championed transplantation in the U.S., are organizing a double-blind test trial here that will be funded by the National Institutes of Health.
Proponents acknowledge that the treatment has a PR problem.
"There is still a gross factor," Van Nood said. "We see this mostly in younger patients. Older patients who have suffered several recurrences are only thinking, 'How can I be relieved of this CDI?'"
monte.morin@latimes.com
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