Swapping Germs: Should Fecal Transplants Become Routine for Debilitating Diarrhea?

A potentially beneficial but unusual treatment for serious intestinal ailments may fall victim to regulatory difficulties

Tony Brain/Photo Researchers, Inc.

Marion Browning of North Providence, R.I., was at her wit’s end. The 79-year-old retired nurse had suffered from chronic diarrhea for almost a year. It began after doctors prescribed antibiotics to treat her diverticulitis, a painful infection of small pouches in the wall of the colon. The regimen also killed friendly bacteria that lived in Browning’s intestines, allowing a toxin-producing organism known as Clostridium difficile to take over and begin eating away at the entire lining of her gut.

For months Browning was in and out of her doctor’s office, getting big-gun antibiotics to suppress the C. difficile infection. Each time a course of treatment ended she would feel better for a while. But her strain of C. difficile was stubborn: a few of the destructive bacteria always survived. Within a few days they would begin multiplying, and the racking diarrhea would recur. After four rounds of antibiotics, her gastroenterologist told her that he had done all he could think of. He recommended that she see Colleen Kelly, a clinical faculty member at Brown University’s medical school, who was trying something new.

Kelly proposed a treatment that sounded both logical and strangely unmedical. Normally, she told Browning, the friendly bacteria that reside in the human intestine maintain a seesawing balance that keeps pathogenic bacteria in check. That equilibrium can be temporarily disrupted—as with standard antibiotic treatment—but it nearly always returns to stability. Browning’s own bacterial community had lost that ability, probably for good. Still, there was a way to restore normality, Kelly said. She could replace Browning’s bacteria completely, by inserting into her colon a diluted sample of stool from someone whose intestinal health was good. If the good bacteria in the donated stool took hold and recolonized her intestine, the C. difficile would be crowded out, and she would be cured.

Browning had never heard of such a procedure—variously called fecal transplant, fecal bacteriotherapy or fecal flora reconstitution—but she was ready to try anything. Kelly asked her to recruit a healthy donor. Browning chose her 49-year-old son. In the fall of 2009 Browning performed the bowel-cleansing routine that precedes a colonoscopy, while her son took an overnight laxative. Kelly diluted the donation, then used colonoscopy instruments to squirt the solution high up in Browning’s large intestine. The diarrhea resolved in two days and has never recurred.

“I can’t understand why more doctors aren’t doing this,” says Browning, now 80. Yet a complex combination of federal regulations and research rules—along with just plain squeamishness—could keep the procedure from helping potentially thousands of people who might benefit.

A Growing Threat
Browning is not alone in being a success story. In medical journals, about a dozen clinicians in the U.S., Europe and Australia have described performing fecal transplants on about 300 C. difficile patients so far. More than 90 percent of those patients recovered completely, an unheard-of proportion. “There is no drug, for anything, that gets to 95 percent,” Kelly says. Plus, “it is cheap and it is safe,” says Lawrence Brandt, a professor of medicine and surgery at the Albert Einstein College of Medicine, who has been performing the procedure since 1999.

So far, though, fecal transplants remain a niche therapy, practiced only by gastroenterologists who work for broad-minded institutions and who have overcome the ick factor. To become widely accepted, recommended by professional societies and reimbursed by insurers, the transplants will need to be rigorously studied in a randomized clinical trial, in which people taking a treatment are assessed alongside people who are not. Kelly and several others have drafted a trial design to submit to the National Institutes of Health for grant funding. Yet an unexpected obstacle stands in their way: before the NIH approves any trial, the substance being studied must be granted “investigational” status by the Food and Drug Administration. The main categories under which the FDA considers things to be investigated are drugs, devices, and biological products such as vaccines and tissues. Feces simply do not fit into any of those categories.

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