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Fecal transplants need better regulation, experts say

The medical practice of fecal transplant sounds too strange to be true, but this procedure shows promise for treating potentially life-threatening bacterial infections. As interest in it grows, experts say more research and regulation is needed to ensure its safety.

In an editorial published this week in the British Medical Journal (BMJ), Dr. Tim Spector, from King's College London, and Rob Knight, Ph.D., from the University of California, San Diego, write that high-quality trials are needed to provide more complete information on the long-term effects of fecal transplants.

"We urgently need more expertise and centers, proper screening of donors, and good long term trials and monitoring procedures in order to provide sensible advice," the authors say.

Fecal transplants are primarily used to treat people with debilitating Clostridium difficile infections. C. difficile is a bacterium passed in feces and spread to food and surfaces when people who are infected don't wash their hands thoroughly, say Mayo Clinic experts. While some aren't sickened by it, the bacteria can cause problems ranging from diarrhea, to dehydration, to life-threatening inflammation of the colon. It's more common in older people, but studies suggest increasing rates of C. difficile infection among younger, healthy individuals have become more severe and more challenging to treat.

The U.S. Centers for Disease Control and Prevention estimated almost half a million infections in the United States in 2011, and 29,000 people died within 30 days of their initial diagnosis with the infection.

When patients take an antibiotic to treat an infection, "good" gut bacteria can be destroyed along with the bacteria causing the illness. Without enough healthy bacteria to keep it in check, C. difficile can grow out of control and produce toxins that attack the lining of the intestine.

The standard of care for C. difficile infection is the antibiotic Vancomycin, said Dr. Darrell Pardi, vice chair of gastroenterology at the Mayo Clinic.

But, the authors wrote, "About a quarter of patients experience a recurrence after an initial mild infection because treatment with antibiotics destroys the diversity of the normal gut microbes and allows C. difficile to flourish." When drug treatment fails, some patients turn to fecal transplants.

Fecal transplant involves transferring fecal matter -- "liquidised stool (or its cryopreserved microbial content)," as the BMJ authors put it -- from a healthy donor into the intestine of a sick patient, usually via colonoscopy. The aim is for the healthy bacteria to recolonize the bowel.

More than 500 centers in the United States offer fecal transplants.

The success rate for fecal transplants in recurrent C. difficile patients is in the ballpark of 85 to 90 percent -- "Better than any other treatment for recurrent C. diff infection," said Pardi.

He said the Mayo Clinic has been performing fecal transplants for two years to treat more than 200 C. difficile patients.

The BMJ authors raised concern that given the ease of performing the procedure at home following instructions on the Internet, patients with many chronic complaints may lose patience and take matters into their own hands, with unpredictable consequences.

Pardi agreed, telling CBS News that home fecal transplants are "a true danger and concern."

Pardi said fecal transplant donors need to be carefully screened. "We have very rigorous screening protocols for donors to maximize safety. We check for any infections. We ask question about their weight and we won't let them donate if they're obese, or if they have colon cancer or polyps. If you do a fecal transplant at home, God knows who your donor is, what you're transferring," he said.

The BMJ authors also warned against adopting the procedure to treat other health issues without proper testing and oversight. "Although advocates suggest that fecal transplantation could be a cure-all for many diseases, these claims are probably too optimistic," they wrote.

They said before the procedure continues to spread and to be used for an increasing variety of health issues -- including irritable bowel syndrome and colitis, diabetes, and obesity -- regulations need to be set in place.

"Fecal transplant looks like a good treatment, but we don't know the long term safety issues and its use in any other condition is really investigational," Pardi warned.

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