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.)