A Canadian doctor has formulated a “poop pill” made of a healthy donor’s processed stool to cure a life-threatening illness. As gross as it sounds, it’s a breakthrough for the 500,000 Americans who contract infections caused by the bacteria Clostridium difficile, or C. diff, yearly. Of those, 14,000 die from serious cases each year.
C. diff is a bacteria sometimes found in the human gut. Most of the time it is not a problem because all the other healthy bacteria in the intestines keep it in check. But when antibiotics kill out too much of the good bacteria, it alters the intestinal ecosystem, allowing C. diff to run wild. Symptoms include watery diarrhea, fever, loss of appetite, nausea, belly pain, and tenderness. Even when not life threatening, C. diff colitis is a very unpleasant illness.
C. diff infections can be treated with an expensive and potentially toxic antibiotic, but it doesn’t always work. Surgery is sometimes needed to remove the infected bowel. Studies have shown that fecal transplantations––giving the infected patient processed stool from a healthy donor–– can restore the balance of gut microbes and cure the patient over 80 percent of the time.
Until now, a fecal transplantation required an invasive procedure like a colonoscopy, enema, or placing a tube through the nose into the small intestine. Processed donor stool, usually from a family member, is given through the tube directly to the gut. In February, the FDA tried to require an investigational permit for this procedure but public outcry forced them to back off by July. Even so, only about 20 doctors in the US do fecal transplants.
Thomas Louie, an infectious disease specialist for the University of Calgary, had a better idea. The poop pill he devised is a noninvasive, less expensive, and possibly more effective way to do the same thing. The donor stool is processed in the laboratory with filters and centrifuges to extract the healthy bacteria and leave the rest of the waste products behind. The bacterial concentrate is then encapsulated with three layers of gelatin so that it can survive a trip to the colon through corrosive gastric acid and powerful digestive enzymes.
“There is no stool left––just stool bugs,” Louie said. “These people are not eating poop.” There are no smelly burps because the contents aren’t released until they are well past the stomach, Louie said.
The process is still complex: Patients are first treated with an antibiotic to kill the C. diff, then days later they take the poop pills––24 to 34 in one sitting. Louie reported treating 27 patients this way with a 100 percent cure rate. His results, delivered to an infectious disease conference in San Francisco this month, included only patients who had suffered at least four C. Diff infections and relapses.
The FDA continues to urge caution until the safety and efficacy of the new treatment is better proven. Unless donors are properly screened and the stool is expertly prepared, parasites, HIV, hepatitis, and other diseases could be transmitted. Other researchers are working on growing the right cocktail of bacteria in a petri dish to use as “probiotic in pill form,” but this will almost certainly be more expensive than Louie’s poop pills.